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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00814372
Other study ID # M102-20814
Secondary ID
Status Terminated
Phase Phase 2
First received December 22, 2008
Last updated March 30, 2015
Start date December 2008
Est. completion date February 2010

Study information

Verified date March 2015
Source CymaBay Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


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 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%.


Recruitment information / eligibility

Status Terminated
Enrollment 242
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
MBX-102
capsule
Placebo
matching placebo
Actos
over-encapsulated to match MBX-102 and placebo
Metformin
greater than or equal to 1500 mg/kg day

Locations

Country Name City State
India Bangalore Diabetes Centre Bangalore
India Diacon Hospital Diabetes & Research Centre Bangalore
India M. S. Ramaiah Memorial Hospital Bangalore
India St. John's Medical College & Hospital Bangalore
India Dr. V. Seshiah Diabetes Care & Research Institute Chennai
India Kamineni Hospitals Pvt, Ltd. Hyderabad Andhra Pradesh
India Mediciti Hospital Hyderabad
India Medwin Hospital Hyderabad
India Diabetes Thyroid Hormone Research Institute Pvt. Ltd. Indore
India Fortis Hospital Jaipur
India Bharti Research Institute of Diabetes & Endocrinology Karnal
India Amrita Institute of Medical Sciences Kochi
India BYL Nair Hospital Mumbai
India Diabetes Action Centre Mumbai
India PD Hindhuja National Hospital Mumbai
India Gandhi Endocrinology & Diabetes Centre Nagpur
India All India Institute of Medical Sciences New Delhi
India Deenanath Mangeshkar Hospital & Research Centre Pune
India Diabetes Care & Research Centre Pune
India Health & Research Centre Trivendrum
India Christian Medical College Vellore
United States Providence Clinical Research Burbank California
United States Nevada Alliance Against Diabetes Las Vegas Nevada
United States American Institute of Research Los Angeles California
United States DGD Research, Inc. San Antonio Texas
United States Piedmont Medical Research Associates Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
CymaBay Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c from baseline and compared to placebo 24 weeks Yes
Secondary Change in fasting plasma glucose (FPG) from baseline and vs. placebo 24 weeks Yes
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