Phase 3
Completed N=1,208
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
Source: ClinicalTrials.gov NCT00103857 ↗Enrolled (actual)
1,208
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 — -0.66; -0.82; -1.13; -1.40 Percent
Summary
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 |
-0.66; -0.82; -1.13; -1.40; -1.90; 0.17 | — |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 |
-17.5; -27.3; -29.3; -47.1; -63.9; 5.8 | — |
| SECONDARY Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 |
-51.9; -53.4; -78.0; -92.5; -116.6; 0.3 | — |
| SECONDARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 |
-0.82; -1.01; -1.34; -1.41; -1.80; -1.10 | — |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 |
-16.0; -29.0; -39.6; -42.5; -55.6; -43.9 | — |
| SECONDARY Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 |
-45.9; -58.6; -76.3; -89.6; -107.9; -80.9 | — |
| SECONDARY Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 |
-1.15; -1.06; -1.34; -1.39; -1.66; -1.39 | — |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104 |
-26.8; -41.4; -43.2; -47.5; -57.3; -45.2 | — |
| SECONDARY Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104 |
-74.1; -72.7; -86.7; -96.2; -110.0; -93.3 | — |
Eligibility Criteria
Inclusion Criteria
54-Week Base Study:
- Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
50-Week Extension Study:
- Patients who complete the 54-week base study are eligible to enter the 50-week extension study
Exclusion Criteria
- Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
Data sourced from ClinicalTrials.gov (NCT00103857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.