Clinical Trial Results:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to Therapy with Placebo added to Saxagliptin in Combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin
Summary
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EudraCT number |
2011-006324-20 |
Trial protocol |
GB CZ PL |
Global end of trial date |
19 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Jul 2016
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Other versions |
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 |
MB102-129
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01646320 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AstraZeneca Pharmaceuticals
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Sponsor organisation address |
Västra Mälarehamnen 9, Södertälje, Sweden, S-151851170
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Public contact |
Eva.Johnsson@astrazeneca.com, AstraZeneca Pharmaceuticals, +46 31 7762484 x 762 484,
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Scientific contact |
Eva Johnsson, Clinical Science Lead, AstraZeneca Pharmaceuticals, +46 31 7762484 x 762 484, Eva.Johnsson@astrazeneca.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 |
10 Jul 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Feb 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to learn if BMS-512148 (dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
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Protection of trial subjects |
Prior to the beginning of the study, the investigator must have had the IRB/IEC’s written approval/favorable opinion of the written informed consent form and any other information to be provided to the subjects. Freely given written informed consent was obtained from each subject or, in those situations where consent could not be given by the subject, their legally acceptable representatives, prior to study participation, including informed consent for any screening procedures conducted to establish subject eligibility in the study.
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Background therapy |
Stable metformin therapy alone for at least 8 weeks prior to screening visit at a dose ≥ 1500 mg per day. Saxagliptin 5 mg was added during the open label treatment period of 8-16 weeks. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Sep 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 |
United States: 148
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Country: Number of subjects enrolled |
Czech Republic: 13
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Country: Number of subjects enrolled |
Mexico: 166
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Country: Number of subjects enrolled |
Poland: 17
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Country: Number of subjects enrolled |
Puerto Rico: 6
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Country: Number of subjects enrolled |
Romania: 25
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Country: Number of subjects enrolled |
Russian Federation: 89
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Country: Number of subjects enrolled |
United Kingdom: 19
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Worldwide total number of subjects |
483
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EEA total number of subjects |
74
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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) |
415
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From 65 to 84 years |
68
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85 years and over |
0
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Recruitment
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Recruitment details |
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial with Dapagliflozin 10 mg added to Saxagliptin 5 mg in Combination with Metformin ≥ 1500 mg compared to placebo added to Saxagliptin in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Arm1: Dapagliflozin (10 mg) + Saxagliptin (5 mg) + Metformin ≥ 1500 mg IR Arm 2: Placebo + Saxagliptin (5 mg) + Metformin IR | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Short-term period (Day 1 to Week 24)
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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, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dapa+Saxa+Met | ||||||||||||||||||||||||||||||
Arm description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dapagliflozin (10 mg) + Saxagliptin (5 mg) + Metformin IR
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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 |
Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablet, Oral, 10mg, Once daily, 24 weeks
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Arm title
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Pla+Saxa+Met | ||||||||||||||||||||||||||||||
Arm description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo + Saxagliptin (5 mg) + Metformin IR
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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 |
Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Of 320 participants randomized, 301 completed Short-Term (ST) treatment period. Of 294 participants entered Long-Term (LT) treatment period, 281 completed |
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Period 2
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Period 2 title |
Long-term Period (Weeks 24 to 52)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dapa+Saxa+Met | ||||||||||||||||||||||||||||||
Arm description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Dapagliflozin (10 mg) + Saxagliptin (5 mg) + Metformin IR
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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 |
Saxagliptin Tablets, Oral, 5mg , Once daily, 52 weeks: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 52 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablet, Oral, 10mg, Once daily, 52 weeks
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Arm title
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Pla+Saxa+Met | ||||||||||||||||||||||||||||||
Arm description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo + Saxagliptin (5 mg) + Metformin IR
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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 |
Saxagliptin Tablets, Oral, 5mg , Once daily, 52 weeks: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 52 weeks Other Names: Glucophage XR: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 52 weeks
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Notes [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Of 320 participants randomized, 301 completed Short-Term (ST) treatment period. Of 294 participants entered Long-Term (LT) treatment period, 281 completed |
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Baseline characteristics reporting groups
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Reporting group title |
Dapa+Saxa+Met
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Reporting group description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Pla+Saxa+Met
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Reporting group description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dapa+Saxa+Met
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Reporting group description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||
Reporting group title |
Pla+Saxa+Met
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Reporting group description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||
Reporting group title |
Dapa+Saxa+Met
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Reporting group description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||
Reporting group title |
Pla+Saxa+Met
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Reporting group description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks |
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End point title |
Adjusted mean change from baseline in Hemoglobin A1C (HbA1c) at Week 24 | ||||||||||||
End point description |
HbA1c was measured as percent of hemoglobin by a central laboratory. HbA1c values recorded after rescue treatment or recorded more than 8 days after last dose date were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.
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End point type |
Primary
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End point timeframe |
From Baseline to Week 24
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Statistical analysis title |
Primary Analysis | ||||||||||||
Statistical analysis description |
Longitudinal repeated measures analysis
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Comparison groups |
Dapa+Saxa+Met v Pla+Saxa+Met
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Number of subjects included in analysis |
316
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [1] | ||||||||||||
Method |
Longitudinal Repeated Measures Analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.72
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.91 | ||||||||||||
upper limit |
-0.53 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.0964
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Notes [1] - Tested at alpha=0.05 |
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End point title |
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 | ||||||||||||
End point description |
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 24
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Statistical analysis title |
Secondary Analysis | ||||||||||||
Statistical analysis description |
Longitudinal repeated measures analysis of FPG
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Comparison groups |
Dapa+Saxa+Met v Pla+Saxa+Met
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Number of subjects included in analysis |
315
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [2] | ||||||||||||
Method |
Longitudinal Repeated Measures Analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-27.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-35.4 | ||||||||||||
upper limit |
-19.6 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
4.015
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Notes [2] - Secondary end points are tested following a sequential testing procedure at alpha=0.05 |
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End point title |
Adjusted mean change from baseline in 120-minute postprandial glucose (PPG) at Week 24 | ||||||||||||
End point description |
2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 24
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Statistical analysis title |
Secondary analysis | ||||||||||||
Statistical analysis description |
ANCOVA analysis of change from baseline in 2-hour postprandial glucose during a MTT at Week 24
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Comparison groups |
Dapa+Saxa+Met v Pla+Saxa+Met
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Number of subjects included in analysis |
266
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [3] | ||||||||||||
Method |
Longitudinal Repeated Measures Analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-35.5
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-46.3 | ||||||||||||
upper limit |
-24.7 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5.493
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Notes [3] - Secondary end points are tested following a sequential testing procedure at alpha=0.05 |
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End point title |
Adjusted mean change from baseline in body weight at week 24 | ||||||||||||
End point description |
Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.
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End point type |
Secondary
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End point timeframe |
From baseline to Week 24
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Statistical analysis title |
Secondary analysis | ||||||||||||
Statistical analysis description |
Longitudinal repeated measures model analysis of change from baseline in Total body weight at week 24
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Comparison groups |
Dapa+Saxa+Met v Pla+Saxa+Met
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Number of subjects included in analysis |
316
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [4] | ||||||||||||
Method |
Longitudinal Repeated Measures Analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-1.5
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.12 | ||||||||||||
upper limit |
-0.89 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.3126
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Notes [4] - Secondary endpoints are tested following a sequential testing procedure at alpha=0.05 |
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End point title |
Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | ||||||||||||
End point description |
Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis.
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End point type |
Secondary
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End point timeframe |
From baseline to week 24
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Statistical analysis title |
Secondary analysis | ||||||||||||
Statistical analysis description |
Analysis of the proportion of subjects achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 (LOCF) using a logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with the adjustment for baseline HbA1c and stratum.
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Comparison groups |
Dapa+Saxa+Met v Pla+Saxa+Met
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Number of subjects included in analysis |
316
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.0001 [5] | ||||||||||||
Method |
Modified logistic regression | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
25.5
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
16.7 | ||||||||||||
upper limit |
34.4 | ||||||||||||
Notes [5] - Secondary end points are tested following a sequential testing procedure at alpha=0.05 |
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Adverse events information
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Timeframe for reporting adverse events |
From baseline to week 52
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
PLA + SAXA + MET
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Reporting group description |
Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
DAPA + SAXA + MET
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Reporting group description |
Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |