NCT00086515

Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 701 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Sitagliptin (MK0431)	Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
DRUG	Placebo/Glipizide 5 mg	Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
DRUG	Metformin	Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
DRUG	Pioglitazone	Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)

Timeline

• Start date: 2004-06-30
• Primary completion: 2005-07-20
• Completion: 2007-02-02
• First posted: 2004-07-05
• Last updated: 2017-05-05
• Results posted: 2010-12-17