NCT00875394

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 30 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	sitagliptin phosphate	sitagliptin 100 mg Once a day (QD) for 24 weeks
DRUG	Comparator: metformin	metformin 850 mg Twice a day (BID) for 24 weeks
DRUG	Comparator: metformin	metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
DRUG	Comparator: Antidiabetic Standard of Care	Patient can take any oral antidiabetic drug (other than metformin)

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-06-27
• Completion: 2008-06-27
• First posted: 2009-04-03
• Last updated: 2017-05-30
• Results posted: 2011-04-20