MK0431 Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus - Full Text View

Purpose

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on Pioglitazone as monotherapy.

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Pioglitazone Pioglitazone hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	MK0431 Phase III Clinical Study - Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus

Further study details as provided by Merck:

Primary Outcome Measures:

HbA1c, safety and tolerability [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment:	130
Study Start Date:	July 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sitagliptin 50 or 100 mg once daily + pioglitazone for 52 weeks.	Drug: sitagliptin phosphate Sitagliptin 50 or 100 mg once daily for 52 weeks Drug: pioglitazone pioglitazone once daily for 12 weeks or 52 weeks
2: Placebo Comparator Placebo + pioglitazone for 12 weeks	Drug: Comparator: placebo (unspecified) Placebo once daily for 12 weeks Drug: pioglitazone pioglitazone once daily for 12 weeks or 52 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 and pioglitazone as monotherapy

Exclusion Criteria:

Patients have type 1 diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372060

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:	2006_029, MK0431-055
First Received:	September 5, 2006
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00372060
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Metabolic Diseases

Pioglitazone

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00372060