Phase 3
Completed N=313
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Source: ClinicalTrials.gov NCT00885352 ↗Enrolled (actual)
313
Serious AEs
2.9%
Results posted
Feb 2012
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 26 — -1.15; -0.40 Percent of glycosylated hemoglobin
Summary
This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 26 |
-1.15; -0.40 | — |
| SECONDARY Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26 |
-54.4; -14.7 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-20.3; -2.8 | — |
Eligibility Criteria
Inclusion Criteria
- has type 2 diabetes and is at least 18 years of age and no older than 78 years of age
- is male or is a female who is unlikely to conceive children
- is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin OR metformin and a sulfonylurea agent
Exclusion Criteria
- has type 1 diabetes
- has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
- is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening
- has had surgery within 30 days of screening or has major surgery planned during the study
- is on or is likely to require treatment with corticosteroids for more than 2 weeks
- has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease
- is human immunodeficiency virus (HIV) positive
- has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening
- has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening
- has severe active peripheral vascular disease
- has a history of cancer or blood disorder
- is pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00885352). 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.