A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator

This study has been completed.

First Received: September 25, 2008 Last Updated: May 11, 2009 History of Changes

Sponsored by:	Metabolic Solutions Development Company
Information provided by:	Metabolic Solutions Development Company
ClinicalTrials.gov Identifier:	NCT00760578

Purpose

The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Placebo Drug: Pioglitazone Drug: MSDC-0160 1 Drug: MSDC-0160 2	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

Further study details as provided by Metabolic Solutions Development Company:

Primary Outcome Measures:

Post Prandial Blood Glucose [ Time Frame: After four weeks of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Characterize pharmacokinetics and pharmacodynamics of MSDC-0160 and identify potential biomarkers [ Time Frame: After four weeks of dosing ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	September 2008
Study Completion Date:	February 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Once daily, oral
2: Active Comparator	Drug: Pioglitazone Once daily, oral
3: Experimental	Drug: MSDC-0160 1 Once daily, oral
4: Experimental	Drug: MSDC-0160 2 Once daily, oral

Eligibility

Criteria

Inclusion Criteria:

Diagnosis of Type 2 Diabetes naive or on metformin
Male and female (postmenopausal or surgically sterilized, 18 to 70 years of age.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760578

Locations

United States, California

Los Angeles, California, United States

Fresno, California, United States

Buena Park, California, United States
United States, Florida

Pembroke Pines, Florida, United States

West Palm Beach, Florida, United States

Miami Gardens, Florida, United States
United States, Michigan

Kalamazoo, Michigan, United States
United States, South Carolina

Greenville, South Carolina, United States
United States, Texas

San Antonio, Texas, United States

Dallas, Texas, United States
United States, Washington

Renton, Washington, United States

Sponsors and Collaborators

Metabolic Solutions Development Company

Investigators

Study Director:

Jerry R Colca, PhD

Metabolic Solutions Development Company

More Information

No publications provided

Responsible Party:	Metabolic Solutions Development Company ( Jerry Colca, PhD/CSO, President )
Study ID Numbers:	MSDC-C003
Study First Received:	September 25, 2008
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00760578 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009