A Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

This study has been completed.

First Received: December 13, 2006 Last Updated: March 5, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00411554

Purpose

The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Condition	Intervention	Phase
Diabetes Mellitus Non-Insulin-Dependent	Drug: sitagliptin phosphate Drug: Comparator: voglibose	Phase III

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness

Drug Information available for: Voglibose Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	MK0431 Phase III Double-Blind Comparative Study - Type 2 Diabetes Mellitus -

Further study details as provided by Merck:

Primary Outcome Measures:

Hba1c
safety and tolerability

Secondary Outcome Measures:

Plasma glucose

Enrollment:	310
Study Start Date:	January 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 12 Weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

Patients have type 1 diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411554

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_051, MK0431-054
Study First Received:	December 13, 2006
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00411554 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Diabetes Mellitus, Type 2
Voglibose
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on May 06, 2009