Trial Outcomes & Findings for Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes (NCT NCT01834274)
NCT ID: NCT01834274
Last Updated: 2015-09-28
Results Overview
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 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
96 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2015-09-28
Participant Flow
Participants took part in the study at 25 sites in the United States and 1 site in Canada from 18 May 2013 (first patient to sign informed consent) to 05 March 2014.
Participants with a diagnosis of Type 2 Diabetes Mellitis were enrolled equally in 1 of 2 treatment groups, once a day fasiglifam 50 mg or Sitagliptin 100 mg in combination with metformin.
Participant milestones
| Measure |
Fasiglifam 50 mg
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
46
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
47
|
41
|
Reasons for withdrawal
| Measure |
Fasiglifam 50 mg
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
Overall Study
Study Termination
|
41
|
38
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Fasiglifam 50 mg
n=50 Participants
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
n=46 Participants
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 7.14 • n=93 Participants
|
55.1 Years
STANDARD_DEVIATION 9.07 • n=4 Participants
|
56.4 Years
STANDARD_DEVIATION 8.17 • n=27 Participants
|
|
Age, Customized
< 65 years
|
41 participants
n=93 Participants
|
41 participants
n=4 Participants
|
82 participants
n=27 Participants
|
|
Age, Customized
≥ 65 years
|
9 participants
n=93 Participants
|
5 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=93 Participants
|
37 participants
n=4 Participants
|
79 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
34 participants
n=93 Participants
|
31 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=93 Participants
|
46 participants
n=4 Participants
|
95 participants
n=27 Participants
|
|
Height
|
168.7 cm
STANDARD_DEVIATION 11.45 • n=93 Participants
|
169.9 cm
STANDARD_DEVIATION 10.79 • n=4 Participants
|
169.3 cm
STANDARD_DEVIATION 11.10 • n=27 Participants
|
|
Weight
|
87.50 kg
STANDARD_DEVIATION 18.769 • n=93 Participants
|
96.09 kg
STANDARD_DEVIATION 19.295 • n=4 Participants
|
91.62 kg
STANDARD_DEVIATION 19.408 • n=27 Participants
|
|
Body Mass Index (BMI)
|
30.77 kg/m^2
STANDARD_DEVIATION 6.112 • n=93 Participants
|
33.13 kg/m^2
STANDARD_DEVIATION 4.787 • n=4 Participants
|
31.90 kg/m^2
STANDARD_DEVIATION 5.614 • n=27 Participants
|
|
Baseline BMI Category
< 30 kg/m^2
|
31 participants
n=93 Participants
|
11 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Baseline BMI Category
≥ 30 kg/m^2
|
19 participants
n=93 Participants
|
35 participants
n=4 Participants
|
54 participants
n=27 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA)1c Category
< 9%
|
27 participants
n=93 Participants
|
28 participants
n=4 Participants
|
55 participants
n=27 Participants
|
|
Baseline Glycosylated Hemoglobin (HbA)1c Category
≥ 9 %
|
23 participants
n=93 Participants
|
18 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Duration of Diabetes
|
10.075 years
STANDARD_DEVIATION 6.530 • n=93 Participants
|
8.877 years
STANDARD_DEVIATION 5.942 • n=4 Participants
|
9.501 years
STANDARD_DEVIATION 6.252 • n=27 Participants
|
|
Smoking Classification
Never smoked
|
38 participants
n=93 Participants
|
29 participants
n=4 Participants
|
67 participants
n=27 Participants
|
|
Smoking Classification
Current smoker
|
7 participants
n=93 Participants
|
9 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Smoking Classification
Ex-smoker
|
5 participants
n=93 Participants
|
8 participants
n=4 Participants
|
13 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants with data available for analysis.
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 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Fasiglifam 50 mg
n=4 Participants
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
n=3 Participants
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
|
-0.63 Percent
Standard Deviation 0.340 • Interval -1.1 to -0.3
|
-0.43 Percent
Standard Deviation 0.208 • Interval -0.6 to -0.6
|
SECONDARY outcome
Timeframe: Week 24Population: As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c \<7% at Week 24 due to the limited enrollment and study duration at the time of study termination.
The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All randomized participants with data available for analysis.
The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Fasiglifam 50 mg
n=4 Participants
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
n=3 Participants
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-0.22 mmol/L
Standard Deviation 1.971
|
1.54 mmol/L
Standard Deviation 5.087
|
Adverse Events
Fasiglifam 50 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fasiglifam 50 mg
n=50 participants at risk
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
n=46 participants at risk
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
General disorders
Chest pain
|
2.0%
1/50 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/46 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Fasiglifam 50 mg
n=50 participants at risk
Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
|
Sitagliptin 100 mg
n=46 participants at risk
Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
4.0%
2/50 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
0.00%
0/46 • 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-blinded study drug.
Safety population included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER