The purpose of this study is to assess the safety and tolerability of MSDC-0602 and to evaluate the reduction in fasting plasma glucose in patients with Type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Placebo Capsules
MSDC-0602 100 mg Capsules
MSDC-0602 250 mg Capsules
Unnamed facility
Goodyear, Arizona, United States
Unnamed facility
Chula Vista, California, United States
Unnamed facility
Los Angeles, California, United States
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.
Time frame: Baseline and 28 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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MSDC-0602 500 mg Capsules
Pioglitazone 45 mg Capsules
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Butte, Montana, United States
Unnamed facility
Greensboro, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
...and 4 more locations
Time frame: Baseline and 28 days