Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
- Registration Number
- NCT01035879
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief Summary
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
- Detailed Description
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- History of type 2 diabetes of at least 3 months duration
- Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
- HbA1c 7.0-8.5% (inclusive) at screening
- BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India
- Any history of type 1 diabetes or diabetic ketoacidosis
- History of major upper GI surgery
- Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
- History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MBX-2982 300 mg MBX-2982 - MBX-2982 25 mg MBX-2982 - Placebo placebo - Sitagliptin 100 mg Sitagliptin - MBX-2982 100 mg MBX-2982 -
- Primary Outcome Measures
Name Time Method Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch 4 weeks
- Secondary Outcome Measures
Name Time Method Evaluate the effect of MBX-2982 on additional glycemic parameters. 4 weeks
Trial Locations
- Locations (14)
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
dgd Research, Inc., a Cetero Research Co.
🇺🇸San Antonio, Texas, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Gandhi Endocrinology & Diabetes Centre
🇮🇳Ramdaspeth, Nagpur, India
Gokula Metropolis Research, MS Ramaiah Memorial Hospital
🇮🇳Bangalore, India
Diabetes Thyroid Hormone Research Institute Pvt Ltd
🇮🇳Indore, M.p., India
Hormone Care Research Centre
🇮🇳Ghaziabad, India
Bangalore Endocrinology & Diabetes Research Centre
🇮🇳Malleshwaram, India
Medulla Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
Nevada Alliance Against Diabetes
🇺🇸Las Vegas, Nevada, United States
Healthy Life Clinical Diagnostic Center
🇬🇪Tbilisi, Georgia
Georgian Diabetes Center
🇬🇪Tbilisi, Georgia
Bharti Research Institute of Diabetes and Endocrinology
🇮🇳Karnal, Haryana, India
Medisys Clinisearch India Pvt Ltd
🇮🇳Bangalore, India