| Trial ID: | L3624 |
| Source ID: | NCT01280695
|
| Associated Drug: |
Placebo
|
| Title: |
A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01280695/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: MSDC-0602 100 mg|DRUG: MSDC-0602 250 mg|DRUG: MSDC-0602 250 mg|DRUG: Pioglitazone
|
| Outcome Measures: |
Primary: Change From Baseline in Fasting Plasma Glucose, To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes., Baseline and 28 days | Secondary: Change From Baseline in HbA1c, To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes., Baseline and 28 days|Change From Baseline in Body Weight, To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes., Baseline and 28 days|Change From Baseline in Hematocrit, To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes., Baseline and 28 days|Change in Fasting Plasma Insulin, To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days, Baseline and 28 days|Change From Baseline in High Molecular Weight Adiponectin, To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes., Baseline and 28 days
|
| Sponsor/Collaborators: |
Sponsor: Metabolic Solutions Development Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
129
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-02
|
| Completion Date: |
2011-06
|
| Results First Posted: |
2013-12-20
|
| Last Update Posted: |
2014-04-14
|
| Locations: |
Goodyear, Arizona, United States|Chula Vista, California, United States|Los Angeles, California, United States|Bradenton, Florida, United States|Hialeah, Florida, United States|Pembroke Pines, Florida, United States|Chicago, Illinois, United States|Butte, Montana, United States|Greensboro, North Carolina, United States|Cincinnati, Ohio, United States|Charleston, South Carolina, United States|Austin, Texas, United States|San Antonio, Texas, United States|Salt Lake City, Utah, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01280695
|
