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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760578
• Other study ID #: MSDC-C003
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2008
• Last updated: March 19, 2013
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2013
• Source: Metabolic Solutions Development Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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:

• Use of diabetes medications other than metformin.

• History of heart failure or previous myocardial infarction.

• Blood pressure great than 160/100 mmHg.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Placebo
Once daily, oral
• Pioglitazone
Once daily, oral
• MSDC-0160 90 mg
Once daily, oral
• MSDC-0160 220 mg
Once daily, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Metabolic Solutions Development Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test	Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.	After four weeks of active therapy	No
Secondary	Change From Baseline in FFAs	Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment	After 28 days of active therapy	No
Secondary	Change From Baseline in Triglycerides	Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment	28 days	No
Secondary	Change From Baseline in HDL	Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment	28 days	No