NCT00511108

Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

A Phase I Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Study the Safety, Efficacy, and Mechanism of Action of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Comparator: sitagliptin phosphate	sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily.
DRUG	Comparator: pioglitazone	pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
DRUG	Comparator: placebo to pioglitazone	pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.
DRUG	Comparator: placebo to sitagliptin	sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily.

Timeline

• Start date: 2007-07-11
• Primary completion: 2009-02-24
• Completion: 2009-02-24
• First posted: 2007-08-03
• Last updated: 2017-05-12
• Results posted: 2010-03-05