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

This study has been terminated.
Sponsor:
Information provided by:
CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00814372
First received: December 22, 2008
Last updated: February 4, 2010
Last verified: January 2010
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MBX-102
Drug: Placebo
Drug: Actos
Phase 2

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

Resource links provided by NLM:


Further study details as provided by CymaBay Therapeutics, Inc.:

Primary Outcome Measures:
  • Change in HbA1c from baseline and compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG) from baseline and vs. placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: December 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBX-102 400 Drug: MBX-102
capsule
Experimental: MBX-102 600 Drug: MBX-102
capsule
Placebo Comparator: Placebo Drug: Placebo
matching placebo
Active Comparator: Actos
30-45 mg
Drug: Actos
over-encapsulated to match MBX-102 and placebo

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 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%.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814372

Locations
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
American Institute of Research
Los Angeles, California, United States, 90017
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, North Carolina
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
DGD Research, Inc.
San Antonio, Texas, United States, 78229
India
Kamineni Hospitals Pvt, Ltd.
Hyderabad, Andhra Pradesh, India, 50008
St. John's Medical College & Hospital
Bangalore, India
Bangalore Diabetes Centre
Bangalore, India
Diacon Hospital Diabetes & Research Centre
Bangalore, India
M. S. Ramaiah Memorial Hospital
Bangalore, India
Dr. V. Seshiah Diabetes Care & Research Institute
Chennai, 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, 400067
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, India
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
Investigators
Principal Investigator: Douglas Denham, M.D. dgd Research, Inc.
Principal Investigator: Thomas W. Littlejohn, M.D. Piedmont Medical Research Associates
Principal Investigator: Michael Guice, M.D. American Institute of Research
Principal Investigator: K. M. Prasanna Kumar, MD M. S. Ramaiah Memorial Hospital
Principal Investigator: Veerasamy Seshiah, MD Dr. V. Seshiah Diabetes Care & Research Institute
Principal Investigator: Sanjay Kalra, MD Bharti Research Institute of Diabetes & Endocrinology
Principal Investigator: Sailesh Lodha, MD Fortis Hospital
Principal Investigator: Ariachery C Ammini, MD All India Institute of Medical Sciences, New Delhi
Principal Investigator: Prema Varthakavi, MD BYL Nair Hospital
Principal Investigator: Sanjiv Shah, MD Diabetes Action Centre
Principal Investigator: Manoj Chadha, MD PD Hindhuja National Hospital & Medical Research Centre
Principal Investigator: Mathew Thomas, MD Health & Research Centre
Principal Investigator: Sanjay Reddy, MD Bangalore Diabetes Centre
Principal Investigator: Ganapati Bantwal, MD St. John's Medical College & Hospital
Principal Investigator: Aravind S Sosale, MD Diacon Hospital Diabetes & Research Centre
Principal Investigator: Vaishali Deshmukh, MD Deenanath Mangeshkar Hospital & Research Centre
Principal Investigator: Abhay Mutha, MD Diabetes Care & Research Centre
Principal Investigator: Nihal Thomas, MD Christian Medical College, Vellore, India
Principal Investigator: Kirtikumar Modi, MD Medwin Hospital
Principal Investigator: Sunil Jain, MD Diabetes Thyroid Hormone Research Institute Pvt. Ltd.
Principal Investigator: Pramod Gandhi, MD Gandhi Endocrinology & Diabetes Centre
Principal Investigator: Rakesh Kumar Sahay, MD Mediciti Hospital
Principal Investigator: Harish Kumar, MD Amrita Institute of Medical Sciences
Principal Investigator: Rubin Savedra, MD Association of International Professionals, dba Nevada Alliance Against Diabetes
Principal Investigator: Teresa Sligh, MD Translational Research Group, Inc. dba Providence Clinical Research
Principal Investigator: Prabha Adhikari, MD Kasturba Medical College Hospital
Principal Investigator: Navneet Agrawal, MD Diabetes, Obesity and Thyroid Center
Principal Investigator: Swamy Miryala, MD Kamineni Hospitals Pvt, Ltd.
  More Information

No publications provided

Responsible Party: Gopal Saha, Director of Clinical Research, Metabolex, Inc.
ClinicalTrials.gov Identifier: NCT00814372     History of Changes
Other Study ID Numbers: M102-20814
Study First Received: December 22, 2008
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014