A clinical trial to study the side effects of a drug, MBX-2982 and also to study how well it works and is tolerated when compared to a placebo and a comparator in patients with Type 2 Diabetes Mellitus.
- Registration Number
- CTRI/2010/091/000162
- Lead Sponsor
- Metabolex Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
a) History of type 2 diabetes of at least 3 months duration
b) 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)
c) HbA1c 7.0-8.5% (inclusive) at screening
d) Fasting glucose should be more than or equal to 105 mg/dL and less than or equal to 250 mg/dL at screening and randomization visit
e) Adult male or female, 18-70 years of age
a) History of outpatient insulin use within last one year
b) Weight loss > 10 pounds in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
c) History of GLP-1 analogue or DPP-4 inhibitor discontinuation due to side effect or lack of efficacy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method