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Sponsored by: |
Metabolic Solutions Development Company |
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Information provided by: | Metabolic Solutions Development Company |
ClinicalTrials.gov Identifier: | NCT00760578 |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 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
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Jerry R Colca, PhD | Metabolic Solutions Development Company |
Responsible Party: | Metabolic Solutions Development Company ( Jerry Colca, PhD/CSO, President ) |
Study ID Numbers: | MSDC-C003 |
Study First Received: | September 25, 2008 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00760578 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |