A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

The 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks

Other names: MK0431

Comparator: voglibose

Drug

voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks

Other names: voglibose

Primary outcomes

Change From Baseline in HbA1c at Week 12

Time frame: Baseline and Week 12

HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.

Secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 12

Time frame: Baseline and Week 12

Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.
Change From Baseline in 2 Hour Postprandial Glucose at Week 12

Time frame: Baseline and Week 12

Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Dec 14, 2006
Registry last updated: Feb 5, 2016

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