MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00289848

Purpose

This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0431, sitagliptin phosphate / Duration of Treatment: 18 weeks Drug: Placebo / Duration of Treatment: 18 weeks	Phase III

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, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Further study details as provided by Merck:

Primary Outcome Measures:

(1) After 18 weeks, to assess the effect of treatment with MK0431 compared with placebo on HbA1c; (2) To Assess the safety and tolerability of MK0431.

Secondary Outcome Measures:

(1) After 18 weeks, to assess the effect of treatment with MK0431 compared with placebo on: (1) Fasting plasma glucose (FPG) and (2) 2-Hour post-prandial glucose, after a standard meal challenge.

Enrollment:	500
Study Start Date:	March 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an HbA1c >=7.5% and <=11% and a FPG >=130 mg/dL and <=280 mg/dL

Exclusion Criteria:

Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289848

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Moniotor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_094, 0431-040
Study First Received:	February 7, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00289848
Health Authority:	India: Indian Council of Medical Research

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