Clinical Trial Results:
A Phase III, Randomized, Double-Blind, Clinical Trial to Study the Efficacy and Safety of MK-0431D (a fixed-dose combination [FDC] of sitagliptin and simvastatin) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) with Inadequate Glycemic Control on Metformin Monotherapy
Summary
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EudraCT number |
2012-001868-29 |
Trial protocol |
LT LV HU CZ PL IT |
Global end of trial date |
01 Nov 2013
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Results information
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Results version number |
v1 |
This version publication date |
27 Apr 2016
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First version publication date |
18 Mar 2015
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MK-0431D-266
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01678820 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
1. To assess the effect of MK-0431D compared to sitagliptin alone on hemoglobin A1c (A1C). 2. To assess the safety and tolerability of MK-0431D.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
The following additional measure defined for this individual study was in place for the protection of trial subjects: participants not meeting specific glycemic goals received rescue therapy initiated with glimepiride (open-label, supplied locally).
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Background therapy |
Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Oct 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 6
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Country: Number of subjects enrolled |
Czech Republic: 11
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Country: Number of subjects enrolled |
Hungary: 18
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Country: Number of subjects enrolled |
Latvia: 1
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Country: Number of subjects enrolled |
Lithuania: 2
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Country: Number of subjects enrolled |
Macedonia, the former Yugoslav Republic of: 3
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Country: Number of subjects enrolled |
Malaysia: 1
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Country: Number of subjects enrolled |
Puerto Rico: 5
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Country: Number of subjects enrolled |
Romania: 11
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Country: Number of subjects enrolled |
Colombia: 3
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Country: Number of subjects enrolled |
Croatia: 2
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Country: Number of subjects enrolled |
Korea, Republic of: 1
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Country: Number of subjects enrolled |
South Africa: 17
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Country: Number of subjects enrolled |
United States: 218
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Worldwide total number of subjects |
299
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EEA total number of subjects |
51
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
251
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From 65 to 84 years |
48
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
All participants randomized population. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sitagliptin/Simvastatin FDC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Sitagliptin 100 mg/simvastatin 40 mg fixed dose combination (FDC) plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be uptitrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sitagliptin/Simvastatin FDC
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Investigational medicinal product code |
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Other name |
MK-0431D
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet administered once daily in the evening.
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Investigational medicinal product name |
Placebo to simvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo to simvastatin administered once daily in the evening.
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Investigational medicinal product name |
Placebo to sitagliptin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo to sitagliptin administered once daily in the evening.
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Investigational medicinal product name |
Metformin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study.
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Investigational medicinal product name |
Glimepiride
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
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Arm title
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Sitagliptin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sitagliptin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Sitagliptin 100 mg oral tablet administered once daily in the evening.
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Investigational medicinal product name |
Placebo to simvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo to simvastatin administered once daily in the evening.
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Investigational medicinal product name |
Placebo to sitagliptin/simvastatin FDC
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Investigational medicinal product code |
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Other name |
MK-0431D
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Matching placebo to sitagliptin/simvastatin FDC tablet administered once daily in the evening.
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Investigational medicinal product name |
Metformin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study.
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Investigational medicinal product name |
Glimepiride
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
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Arm title
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Simvastatin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Simvastatin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Simvastatin 40 mg tablet administered orally once daily in the evening.
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Investigational medicinal product name |
Placebo to sitagliptin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo to sitagliptin administered once daily in the evening.
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Investigational medicinal product name |
Placebo to sitagliptin/simvastatin FDC
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Investigational medicinal product code |
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Other name |
MK-0431D
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Matching placebo to sitagliptin/simvastatin FDC tablet administered once daily in the evening.
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Investigational medicinal product name |
Metformin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study.
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Investigational medicinal product name |
Glimepiride
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
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Baseline characteristics reporting groups
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Reporting group title |
Sitagliptin/Simvastatin FDC
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Reporting group description |
Sitagliptin 100 mg/simvastatin 40 mg fixed dose combination (FDC) plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be uptitrated to 6 mg once daily) as rescue therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sitagliptin
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Reporting group description |
Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Simvastatin
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|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Sitagliptin/Simvastatin FDC
|
||
Reporting group description |
Sitagliptin 100 mg/simvastatin 40 mg fixed dose combination (FDC) plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be uptitrated to 6 mg once daily) as rescue therapy. | ||
Reporting group title |
Sitagliptin
|
||
Reporting group description |
Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | ||
Reporting group title |
Simvastatin
|
||
Reporting group description |
Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. |
|
|||||||||||||
End point title |
Change from baseline in A1C at Week 16 (sitagliptin/simvastatin FDC vs. sitagliptin) [1] | ||||||||||||
End point description |
A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary endpoint only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary endpoints.
Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This primary endpoint only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented under secondary endpoints. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
non-inferiority [2] | ||||||||||||
P-value |
= 0.267 [3] | ||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||
Point estimate |
0.19
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.14 | ||||||||||||
upper limit |
0.52 | ||||||||||||
Notes [2] - Due to inadequate sample size, the primary hypothesis of non-inferiority was not tested. Nominal p-value is provided. [3] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||
End point title |
Number of participants who experienced at least one adverse event (AE) | ||||||||||||
End point description |
Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
All participants as treated population defined as all randomized participants who received at least one dose of study drug.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Up to 16 weeks for non-serious AEs; up to 18 weeks for serious AEs
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Difference in percents | ||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other [4] | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percents | ||||||||||||
Point estimate |
-0.4
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-10.2 | ||||||||||||
upper limit |
9.3 | ||||||||||||
Notes [4] - Based on Miettinen & Nurminen method |
|||||||||||||
Statistical analysis title |
Difference in percents | ||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other [5] | ||||||||||||
Method |
|||||||||||||
Parameter type |
Difference in percents | ||||||||||||
Point estimate |
-4.3
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-14.7 | ||||||||||||
upper limit |
5.8 | ||||||||||||
Notes [5] - Based on Miettinen & Nurminen method |
|
|||||||||||||
End point title |
Number of participants who discontinued study drug due to an adverse event [6] | ||||||||||||
End point description |
Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
All participants as treated population defined as all randomized participants who received at least one dose of study drug.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Up to 16 weeks
|
||||||||||||
Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As pre-specified in the protocol, 95% confidence intervals were only provided for events with an incidence of at least 4 participants in at least one of the treatment arms. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Change from baseline in A1C at Week 16 (sitagliptin/simvastatin FDC vs. simvastatin) [7] | ||||||||||||
End point description |
A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||
Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This secondary endpoint only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented under primary endpoints. |
|||||||||||||
|
|||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority [8] | ||||||||||||
P-value |
< 0.001 [9] | ||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||
Point estimate |
-0.62
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.95 | ||||||||||||
upper limit |
-0.28 | ||||||||||||
Notes [8] - Due to inadequate sample size, the secondary hypothesis was not tested. Nominal p-value is provided. [9] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Change from baseline in FPG at Week 16 | ||||||||||||||||
End point description |
Change from baseline reflects the Week 16 value minus the Week 0 value.
FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [10] | ||||||||||||||||
P-value |
= 0.856 [11] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
1.7
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-17.1 | ||||||||||||||||
upper limit |
20.6 | ||||||||||||||||
Notes [10] - There is no hypothesis comparing Sitagliptin/Simvastatin vs. Sitagliptin for FPG. Nominal p-value is provided. [11] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [12] | ||||||||||||||||
P-value |
= 0.002 [13] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-29.2
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-47.9 | ||||||||||||||||
upper limit |
-10.6 | ||||||||||||||||
Notes [12] - There is no hypothesis comparing Sitagliptin/Simvastatin vs. Simvastatin for FPG. Nominal p-value is provided. [13] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in LDL-C at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority [14] | ||||||||||||||||
P-value |
< 0.001 [15] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-25.6
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-35.6 | ||||||||||||||||
upper limit |
-15.6 | ||||||||||||||||
Notes [14] - Due to inadequate sample size, the secondary hypothesis was not tested. Nominal p-value is provided. [15] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [16] | ||||||||||||||||
P-value |
= 0.286 [17] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
5.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-4.5 | ||||||||||||||||
upper limit |
15.2 | ||||||||||||||||
Notes [16] - There is no hypothesis comparing Sitagliptin/Simvastatin vs. Simvastatin for LDL-C-lowering. Nominal p-value is provided. [17] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in TC at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [18] | ||||||||||||||||
P-value |
< 0.001 [19] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-18.1
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-24.2 | ||||||||||||||||
upper limit |
-12 | ||||||||||||||||
Notes [18] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for TC-lowering. Nominal p-value is provided. [19] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [20] | ||||||||||||||||
P-value |
= 0.99 [21] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
0
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-6 | ||||||||||||||||
upper limit |
6 | ||||||||||||||||
Notes [20] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for TC-lowering. Nominal p-value is provided. [21] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in Apo B at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%. FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
194
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [22] | ||||||||||||||||
P-value |
< 0.001 [23] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-20.2
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-28.3 | ||||||||||||||||
upper limit |
-12.2 | ||||||||||||||||
Notes [22] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for Apo B-lowering. Nominal p-value is provided. [23] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [24] | ||||||||||||||||
P-value |
= 0.469 [25] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
2.9
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-5 | ||||||||||||||||
upper limit |
10.7 | ||||||||||||||||
Notes [24] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for Apo B-lowering. Nominal p-value is provided. [25] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in non-HDL-C at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
196
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [26] | ||||||||||||||||
P-value |
< 0.001 [27] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-24.4
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-32.6 | ||||||||||||||||
upper limit |
-16.3 | ||||||||||||||||
Notes [26] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for non-HDL-C-lowering. Nominal p-value is provided. [27] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [28] | ||||||||||||||||
P-value |
= 0.937 [29] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
0.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-7.7 | ||||||||||||||||
upper limit |
8.3 | ||||||||||||||||
Notes [28] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for non-HDL-C-lowering. Nominal p-value is provided. [29] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in TG at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in estimated means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [30] | ||||||||||||||||
P-value |
= 0.068 [31] | ||||||||||||||||
Method |
Robust Regression | ||||||||||||||||
Parameter type |
Difference in estimated means | ||||||||||||||||
Point estimate |
-15.5
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-32.2 | ||||||||||||||||
upper limit |
1.2 | ||||||||||||||||
Notes [30] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for TG-lowering. Nominal p-value is provided. [31] - Based on a robust regression using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations. |
|||||||||||||||||
Statistical analysis title |
Difference in estimated means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [32] | ||||||||||||||||
P-value |
= 0.365 [33] | ||||||||||||||||
Method |
Robust Regression | ||||||||||||||||
Parameter type |
Difference in estimated means | ||||||||||||||||
Point estimate |
-10.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-33.6 | ||||||||||||||||
upper limit |
13 | ||||||||||||||||
Notes [32] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for TG-lowering. Nominal p-value is provided. [33] - Based on a robust regression using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations. |
|
|||||||||||||||||
End point title |
Percent change from baseline in HDL-C at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [34] | ||||||||||||||||
P-value |
= 0.857 [35] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
0.5
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-4.8 | ||||||||||||||||
upper limit |
5.8 | ||||||||||||||||
Notes [34] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for HDL-C-lowering. Nominal p-value is provided. [35] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [36] | ||||||||||||||||
P-value |
= 0.879 [37] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
0.4
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-4.8 | ||||||||||||||||
upper limit |
5.6 | ||||||||||||||||
Notes [36] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for HDL-C-lowering. Nominal p-value is provided. [37] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percent change from baseline in VLDL-C at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.
FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Baseline and Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
196
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [38] | ||||||||||||||||
P-value |
= 0.004 [39] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-30.4
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-51 | ||||||||||||||||
upper limit |
-9.7 | ||||||||||||||||
Notes [38] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Sitagliptin for VLDL-C-lowering. Nominal p-value is provided. [39] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|||||||||||||||||
Statistical analysis title |
Difference in least squares means | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [40] | ||||||||||||||||
P-value |
= 0.141 [41] | ||||||||||||||||
Method |
Longitudinal Data Analysis Model | ||||||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||||||
Point estimate |
-15.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-35.8 | ||||||||||||||||
upper limit |
5.1 | ||||||||||||||||
Notes [40] - There is no hypothesis comparing Sitagliptin/Simvastatin FDC vs. Simvastatin for VLDL-C-lowering. Nominal p-value is provided. [41] - Based on a longitudinal data analysis model including terms for region, treatment, time, and the interaction of time by treatment with the restriction of common mean across treatment groups at baseline. |
|
|||||||||||||||||
End point title |
Percentage of participants with A1C level <7% at Week 16 | ||||||||||||||||
End point description |
Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed. FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 16
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
Difference in percents | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Sitagliptin
|
||||||||||||||||
Number of subjects included in analysis |
197
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [42] | ||||||||||||||||
Method |
|||||||||||||||||
Parameter type |
Difference in percents | ||||||||||||||||
Point estimate |
0.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
-12.2 | ||||||||||||||||
upper limit |
12.9 | ||||||||||||||||
Notes [42] - Based on Miettinen & Nurminen method. Missing data were imputed by multiple imputations. |
|||||||||||||||||
Statistical analysis title |
Difference in percents | ||||||||||||||||
Comparison groups |
Sitagliptin/Simvastatin FDC v Simvastatin
|
||||||||||||||||
Number of subjects included in analysis |
198
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
other [43] | ||||||||||||||||
Method |
|||||||||||||||||
Parameter type |
Difference in percents | ||||||||||||||||
Point estimate |
12.3
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
2-sided
|
||||||||||||||||
lower limit |
0.7 | ||||||||||||||||
upper limit |
24 | ||||||||||||||||
Notes [43] - Based on Miettinen & Nurminen method. Missing data were imputed by multiple imputations. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to 18 weeks
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
All participants as treated population defined as all randomized participants who received at least one dose of study drug. Serious adverse events include data after rescue therapy and non-serious adverse events exclude data after rescue therapy
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sitagliptin/Simvastatin FDC
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Sitagliptin 100 mg/simvastatin 40 mg fixed dose combination (FDC) plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be uptitrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sitagliptin
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Simvastatin
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse event exceeded the 5% threshold for any reporting group. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
The early termination of this study resulted in a smaller number of participants analyzed. |