NCT00545584

Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,512 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Conditions

• Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Type	Name	Description
DRUG	sitagliptin phosphate	sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks
BEHAVIORAL	Comparator: Diet	Diet
BEHAVIORAL	Comparator: Physical Activity	Physical Activity

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-19
• Completion: 2009-11-19
• First posted: 2007-10-17
• Last updated: 2017-05-12
• Results posted: 2011-05-11