NCT00701090

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,035 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Conditions

• Type 2 Diabetes Mellitus, Non Insulin Dependent
• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	sitagliptin	Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
DRUG	Comparator: glimepiride	glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
DRUG	open-label metformin	open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-06-19
• Last updated: 2017-03-10
• Results posted: 2010-10-05