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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

December 22, 2008
February 4, 2010
December 2008
January 2010   (final data collection date for primary outcome measure)
Change in HbA1c from baseline and compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00814372 on ClinicalTrials.gov Archive Site
Change in fasting plasma glucose (FPG) from baseline and vs. placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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%.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MBX-102
    capsule
  • Drug: Placebo
    matching placebo
  • Drug: Actos
    over-encapsulated to match MBX-102 and placebo
  • Experimental: MBX-102 400
    Intervention: Drug: MBX-102
  • Experimental: MBX-102 600
    Intervention: Drug: MBX-102
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Actos
    30-45 mg
    Intervention: Drug: Actos
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00814372
M102-20814
No
Gopal Saha, Director of Clinical Research, Metabolex, Inc.
CymaBay Therapeutics, Inc.
Not Provided
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.
CymaBay Therapeutics, Inc.
January 2010

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