Trial Outcomes & Findings for Initial Combination With Pioglitazone Study (0431-064) (NCT NCT00397631)
NCT ID: NCT00397631
Last Updated: 2017-05-12
Results Overview
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
520 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2017-05-12
Participant Flow
First Patient In: 01-Feb-2007; Last Patient Last Visit: 28-Jun-2008; 60 study sites worldwide.
Patients ≥18 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (HbA1C ≥8% and ≤12%) on diet and exercise alone were eligible for randomization.
Participant milestones
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
259
|
|
Overall Study
COMPLETED
|
231
|
215
|
|
Overall Study
NOT COMPLETED
|
30
|
44
|
Reasons for withdrawal
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
7
|
10
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
14
|
|
Overall Study
protocol discontinuation criteria
|
1
|
4
|
Baseline Characteristics
Initial Combination With Pioglitazone Study (0431-064)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
n=261 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
n=259 Participants
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
Total
n=520 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
138 participants
n=5 Participants
|
134 participants
n=7 Participants
|
272 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
85 participants
n=5 Participants
|
83 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
27 participants
n=5 Participants
|
34 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
HbA1c (Hemoglobin A1C)
|
9.5 Percent
STANDARD_DEVIATION 1.2 • n=5 Participants
|
9.5 Percent
STANDARD_DEVIATION 1.2 • n=7 Participants
|
9.5 Percent
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
n=251 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
n=246 Participants
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
|
-2.38 Percent
Interval -2.55 to -2.21
|
-1.49 Percent
Interval -1.66 to -1.32
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
n=256 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
n=253 Participants
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
|
-63.0 mg/dL
Interval -68.3 to -57.6
|
-40.2 mg/dL
Interval -45.6 to -34.8
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
n=216 Participants
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
n=211 Participants
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
|
-113.6 mg/dL
Interval -122.4 to -104.8
|
-68.9 mg/dL
Interval -77.8 to -60.0
|
Adverse Events
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Pioglitazone 30 mg q.d.
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Ear and labyrinth disorders
Any Ear and labyrinth disorders
|
0.38%
1/261
|
0.00%
0/259
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.38%
1/261
|
0.00%
0/259
|
|
Gastrointestinal disorders
Any Gastrointestinal disorders
|
0.77%
2/261
|
0.00%
0/259
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.38%
1/261
|
0.00%
0/259
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.38%
1/261
|
0.00%
0/259
|
|
Infections and infestations
Any Infections and infestations
|
0.77%
2/261
|
0.39%
1/259
|
|
Infections and infestations
Abscess limb
|
0.00%
0/261
|
0.39%
1/259
|
|
Infections and infestations
Bronchitis bacterial
|
0.38%
1/261
|
0.00%
0/259
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.38%
1/261
|
0.00%
0/259
|
|
Injury, poisoning and procedural complications
Any Injury, poisoning and procedural complications
|
0.38%
1/261
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/261
|
0.39%
1/259
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.38%
1/261
|
0.00%
0/259
|
|
Nervous system disorders
Any Nervous system disorders
|
0.00%
0/261
|
0.77%
2/259
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/261
|
0.39%
1/259
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/261
|
0.39%
1/259
|
|
Psychiatric disorders
Any Psychiatric disorders
|
0.38%
1/261
|
0.00%
0/259
|
|
Psychiatric disorders
Impulsive behaviour
|
0.38%
1/261
|
0.00%
0/259
|
|
Skin and subcutaneous tissue disorders
Any Skin and subcutaneous tissue disorders
|
0.38%
1/261
|
0.00%
0/259
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.38%
1/261
|
0.00%
0/259
|
|
Vascular disorders
Any Vascular disorders
|
0.00%
0/261
|
0.39%
1/259
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/261
|
0.39%
1/259
|
Other adverse events
| Measure |
Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.
The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
|
Pioglitazone 30 mg q.d.
The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
|
|---|---|---|
|
Infections and infestations
Any Infections and infestations
|
3.1%
8/261
|
5.4%
14/259
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
8/261
|
5.4%
14/259
|
|
Nervous system disorders
Any Nervous system disorders
|
3.4%
9/261
|
5.0%
13/259
|
|
Nervous system disorders
Headache
|
3.4%
9/261
|
5.0%
13/259
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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