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

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

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion criteria

Patients Have Type 1 Diabetes Mellitus

Treatment and study plan

sitagliptin phosphate

Drug

100 mg once daily (QD), taken orally for 4 weeks

Other names: MK0431

Comparator: placebo

Drug

Placebo tablet, QD, taken orally for 4 weeks

Comparator: Sitagliptin

Drug

50 mg twice daily (BID), taken orally for 4 weeks

Other names: MK0431

Primary outcomes

Change From Baseline in 24-hour Weighted Mean Plasma Glucose

Time frame: 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 outcomes

Change From Baseline in Plasma Glucose

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 23, 2008
Registry last updated: May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed