Status:
TERMINATED
Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
Lead Sponsor:
Gilead Sciences
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administ...
Detailed Description
Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group ...
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
- Male or female, 18-70 years of age
- All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
- Female patients must not be pregnant or lactating
- BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
- HbA1c ≥ 7.5%, ≤ 10.5%
- FPG ≥ 120 mg/dL, ≤ 240 mg/dL
Exclusion
- History of diabetes secondary to pancreatitis or pancreatectomy
- Any history of ketoacidosis
- History of insulin use within last one year (insulin use while hospitalized is acceptable)
- Weight loss \> 10 pounds in the three months prior to screening visit
- History of TZD use (Actos® or Avandia®) within 6 months of screening visit
- History of TZD discontinuation due to side effect or lack of efficacy
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00814372
Start Date
December 1 2008
End Date
February 1 2010
Last Update
April 17 2015
Active Locations (26)
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1
Providence Clinical Research
Burbank, California, United States, 91505
2
American Institute of Research
Los Angeles, California, United States, 90017
3
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
4
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103