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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 18

2-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

Page last updated: August 23, 2015

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