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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00814372
• Other study ID #: M102-20814
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

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