Title

Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of MBX-102/JNJ-39659100 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Terminated
  • Study Participants

    242
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).
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 will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.
Study Started
Dec 31
2008
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Apr 17
2015
Estimate

Drug MBX-102

capsule

Drug Placebo

matching placebo

Drug Actos

over-encapsulated to match MBX-102 and placebo

Drug Metformin

greater than or equal to 1500 mg/kg day

MBX-102 400 Experimental

MBX-102 600 Experimental

Placebo Placebo Comparator

Actos Active Comparator

30-45 mg

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
No Results Posted