Trial Outcomes & Findings for 30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064) (NCT NCT01028391)
NCT ID: NCT01028391
Last Updated: 2017-05-12
Results Overview
HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
317 participants
Primary outcome timeframe
Baseline and 54 Weeks
Results posted on
2017-05-12
Participant Flow
First patient in the 30-week extension study: 21-Sep-2007. Last patient last visit of the 30-week extension study: 23-Jan-2009; 53 study centers worldwide.
Patients ≥18 years with type 2 diabetes mellitus (T2DM) and hemoglobin A1c (HbA1c) of 8-12% on diet/exercise meeting all other entry criteria were eligible for participation in the 24-week base study. Patients who completed the base study with \>75% study drug compliance were eligible to enter the 30-week extension study at participating sites.
Participant milestones
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
153
|
|
Overall Study
COMPLETED
|
150
|
142
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Needed excluded medication
|
1
|
1
|
Baseline Characteristics
30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
n=164 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
n=153 Participants
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
93 participants
n=5 Participants
|
85 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
9.4 Percent
STANDARD_DEVIATION 1.2 • n=5 Participants
|
9.4 Percent
STANDARD_DEVIATION 1.2 • n=7 Participants
|
9.4 Percent
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 54 WeeksPopulation: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54.
HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
n=161 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
n=149 Participants
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54
|
-2.37 Percent HbA1c
Interval -2.54 to -2.19
|
-1.86 Percent HbA1c
Interval -2.04 to -1.68
|
SECONDARY outcome
Timeframe: Baseline and Week 54Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54.
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
n=163 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
n=152 Participants
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54
|
-61.3 mg/dL
Interval -66.7 to -55.9
|
-52.8 mg/dL
Interval -58.4 to -47.2
|
Adverse Events
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Pioglitazone 45 mg q.d.
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
n=164 participants at risk
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
n=153 participants at risk
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Cardiac disorders
All Cardiac Disorders
|
0.61%
1/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.00%
0/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.61%
1/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.00%
0/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
All Infections and Infestations
|
1.8%
3/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
1.3%
2/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
Appendicitis
|
1.2%
2/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.00%
0/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.65%
1/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
Lobar pneumonia
|
0.61%
1/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.00%
0/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.65%
1/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Nervous system disorders
All Nervous System Disorders
|
0.61%
1/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.65%
1/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.65%
1/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Nervous system disorders
Presyncope
|
0.61%
1/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
0.00%
0/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
Other adverse events
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.
n=164 participants at risk
The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
|
Pioglitazone 45 mg q.d.
n=153 participants at risk
The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
|
|---|---|---|
|
Infections and infestations
All Infections and Infestations
|
4.9%
8/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
5.2%
8/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
8/164 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
5.2%
8/153 • Weeks 24 to 54 (i.e., the entire 30-week extension study)
Non-serious adverse experience results represent those events included in the prespecified primary analysis of safety (i.e., excluding events that occurred following the initiation of glycemic rescue therapy) for this study.
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER