Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CymaBay Therapeutics, Inc.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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