Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Phase 2

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00758069
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-03
• Primary Completion: 2006-02-13
• Study Completion: 2006-02-13
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Results First Submitted: 2009-08-17
• Results First Submitted QC: 2009-09-24
• Results First Posted: 2009-09-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

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Exclusion Criteria

• Patients Have Type 1 Diabetes Mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	sitagliptin phosphate	Sitagliptin 100 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 24-hour Weighted Mean Plasma Glucose	Baseline and Week 4	Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Plasma Glucose	Baseline and Week 4	Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.