Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
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: Rosiglitazone (Drug); Comparator: Placebo (Drug); Comparator: Metformin (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
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients
with type 2 diabetes.
Clinical Details
Official title: A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Hemoglobin A1C (A1C) at Week 18
Secondary outcome: Fasting Plasma Glucose (FPG) at Week 182-hour Post-meal Glucose (PMG) at Week 18
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has Type 2 diabetes
- Currently taking metformin >1500 mg/day for at least 10 weeks
- Male or female
Exclusion Criteria:
- Patient has peripheral edema
- History of type 1 diabetes
- Patient required insulin within prior 8 weeks
- Have participated or are currently participating in another study with an
investigational compound or device within 12 weeks of starting this study
- Participating in a weight loss program
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Related publications: Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.
Starting date: June 2006
Last updated: August 21, 2015
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