Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Sitagliptin (Drug); Comparator: Placebo (Drug); Pioglitazone (Drug); Metformin (Drug); Glipizide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and Pioglitazone
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 26
Secondary outcome: Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Eligibility
Minimum age: 18 Years.
Maximum age: 78 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: July 27, 2015
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