Phase 3
Completed N=427
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
Source: ClinicalTrials.gov NCT01076075 ↗Enrolled (actual)
427
Serious AEs
3.6%
Results posted
Aug 2012
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (%) at Week 24 — -0.84; -0.16 Percentage of glycosylated hemoglobin — p=<0.001
Summary
This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (%) at Week 24 |
-0.84; -0.16 | <0.001 sig |
| PRIMARY Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54 |
120; 122 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to An Adverse Event |
3; 9 | — |
| SECONDARY Change From Baseline in 2-hour Post-Meal Glucose at Week 24 |
-36.8; -3.3 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 24 |
-13.2; 5.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Hemoglobin A1C of ≥7.5% and ≤10.5%
- Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
- Male, or a female who is highly unlikely to conceive
Exclusion Criteria
- Type 1 diabetes mellitus or ketoacidosis
- Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
- On a weight loss program not in the maintenance phase or on a weight loss medication
- History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
- HIV positive
- Pregnant
Data sourced from ClinicalTrials.gov (NCT01076075). 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.