A Study of an Investigational Study Drug for Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00127192

Purpose

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: sitagliptin phosphate Drug: Comparator: placebo (unspecified)	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin phosphate Sitagliptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	MK0431 Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus

Further study details as provided by Merck:

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment:	363
Study Start Date:	July 2005
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo QD 12-week	Drug: Comparator: placebo (unspecified) placebo QD 12-weeks
2: Experimental 25 mg QD 12-week	Drug: sitagliptin phosphate sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
3: Experimental 50 mg QD 12-week	Drug: sitagliptin phosphate sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
4: Experimental 100 mg QD 12-week	Drug: sitagliptin phosphate sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
5: Experimental 200 mg QD 12-week	Drug: sitagliptin phosphate sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127192

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_037, MK0431-044
Study First Received:	August 3, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00127192
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009