Clinical Trial Results:
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Parallel-Group, Multicenter Study to Evaluate the Glycemic Effects and Safety of Fasiglifam 25 mg Twice Daily and 50 mg Once Daily on Glycemic Control in Subjects with Type 2 Diabetes
Summary
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EudraCT number |
2013-000886-35 |
Trial protocol |
SK |
Global end of trial date |
31 Jan 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Mar 2016
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First version publication date |
06 Aug 2015
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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 |
TAK-875_203
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01982253 | ||
WHO universal trial number (UTN) |
U1111-1146-1263 | ||
Sponsors
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Sponsor organisation name |
Takeda
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Sponsor organisation address |
61 Aldwych, London, United Kingdom, WC2B 4AE
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Public contact |
Program Manager, Takeda Development Centre Europe Ltd., 0044 0203116 8000, clinicaloperations@tgrd.com
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Scientific contact |
Program Manager, Takeda Development Centre Europe Ltd., 0044 0203116 8000, clinicaloperations@tgrd.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 |
28 Aug 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jan 2014
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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 |
To evaluate the efficacy of fasiglifam 25 mg BID and fasiglifam 50 mg QD on glycemic control over a 12-week treatment period in subjects with type 2 diabetes mellitus (T2DM) who are inadequately controlled on diet and exercise alone.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Oct 2013
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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: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
0
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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) |
9
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects took part in the study at 5 investigative sites in the United States from 21 October 2013 to 31 January 2014. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Subjects with a historical diagnosis of T2DM and inadequate glycemic control on diet and exercise alone were enrolled in 1 of 3 treatment groups, placebo, fasiglifam 25 milligram (mg) twice daily (BID) and fasiglifam 50 mg once daily (QD). | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (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, Carer, Assessor | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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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 |
Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
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Arm title
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Fasiglifam 25 mg BID | ||||||||||||||||||||||||
Arm description |
Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Fasiglifam
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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 |
Fasiglifam 25 mg tablets, orally, twice daily for up to Day 47.
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Arm title
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Fasiglifam 50 mg QD | ||||||||||||||||||||||||
Arm description |
Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Fasiglifam
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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 |
Fasiglifam 50 mg tablet, orally, once daily for up to Day 47.
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Investigational medicinal product name |
Placebo
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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 |
Fasiglifam placebo-matching tablet, orally, once daily for up to Day 47.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fasiglifam 25 mg BID
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Reporting group description |
Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fasiglifam 50 mg QD
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Reporting group description |
Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47. | ||
Reporting group title |
Fasiglifam 25 mg BID
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Reporting group description |
Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47. | ||
Reporting group title |
Fasiglifam 50 mg QD
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Reporting group description |
Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47. |
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End point title |
Change From Baseline in HbA1c at Week 12 [1] | ||||||||||||||||
End point description |
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline. In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
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End point type |
Primary
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End point timeframe |
Baseline and Week 12
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Notes [1] - 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: In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced. |
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Notes [2] - Limited enrollment at the time of study termination. [3] - Limited enrollment at the time of study termination. [4] - Limited enrollment at the time of study termination. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | ||||||||||||||||
End point description |
The change between the FPG value collected at week 12 or final visit relative to baseline. In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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Notes [5] - Limited enrollment at the time of study termination. [6] - Limited enrollment at the time of study termination. [7] - Limited enrollment at the time of study termination. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
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Adverse event reporting additional description |
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the subject or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fasiglifam 25 mg BID
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Reporting group description |
Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fasiglifam 50 mg QD
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Reporting group description |
Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||||||
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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 |