A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator
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
1 other identifier
interventional
86
1 country
8
Brief Summary
The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Sep 2008
Shorter than P25 for phase_2 type-2-diabetes-mellitus
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
May 3, 2013
CompletedMay 3, 2013
March 1, 2013
4 months
September 25, 2008
March 19, 2013
March 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.
28 days
Secondary Outcomes (4)
Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test
After four weeks of active therapy
Change From Baseline in FFAs
After 28 days of active therapy
Change From Baseline in Triglycerides
28 days
Change From Baseline in HDL
28 days
Study Arms (4)
Placebo
PLACEBO COMPARATORMicrocrystaline cellulose once daily
Pioglitazone
ACTIVE COMPARATORPioglitazone 45 mg once daily
MSDC-0160 90 mg
EXPERIMENTALMSDC-0160 90 mg once daily
MSDC-0160 220 mg
EXPERIMENTALMSDC-0160 220 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 Diabetes naive or on metformin
- Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.
You may not qualify if:
- Use of diabetes medications other than metformin.
- History of heart failure or previous myocardial infarction.
- Blood pressure great than 160/100 mmHg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Miami Gardens, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Renton, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jerry Colca, PhD
- Organization
- Metabolic Solutions Development Company
Study Officials
- STUDY DIRECTOR
Jerry R Colca, PhD
Metabolic Solutions Development Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
September 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
May 3, 2013
Results First Posted
May 3, 2013
Record last verified: 2013-03