Phase 3
Completed N=492
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Source: ClinicalTrials.gov NCT00541450 ↗Enrolled (actual)
492
Serious AEs
1.6%
Results posted
Apr 2011
Primary outcomePrimary: Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks — -1.75; -1.38 percentage of glycosylated hemoglobin — p=0.002
Summary
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks |
-1.75; -1.38 | 0.002 sig |
| PRIMARY Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks |
-1.03; -0.87 | — |
| SECONDARY Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks |
-90.3; -69.1 | 0.001 sig |
| SECONDARY Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks |
-52.8; -50.1 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks |
-45.8; -37.6 | 0.030 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks |
-26.6; -28.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 18 and 78 with type 2 diabetes mellitus
- Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months
Exclusion Criteria
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor
Data sourced from ClinicalTrials.gov (NCT00541450). 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.