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

March 30, 2015 updated by: CymaBay Therapeutics, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, 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
      • Chennai, India
        • Dr. V. Seshiah Diabetes Care & Research Institute
      • Hyderabad, India
        • Mediciti Hospital
      • Hyderabad, India
        • Medwin Hospital
      • Indore, India
        • Diabetes Thyroid Hormone Research Institute Pvt. Ltd.
      • Jaipur, India
        • Fortis Hospital
      • Karnal, India
        • Bharti Research Institute of Diabetes & Endocrinology
      • Kochi, India
        • Amrita Institute of Medical Sciences
      • Mumbai, India, 400067
        • Diabetes Action Centre
      • Mumbai, India
        • BYL Nair Hospital
      • Mumbai, India
        • PD Hindhuja National Hospital
      • Nagpur, India
        • Gandhi Endocrinology & Diabetes Centre
      • New Delhi, India
        • All India Institute of medical Sciences
      • Pune, India
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, India
        • Diabetes Care & Research Centre
      • Trivendrum, India
        • Health & Research Centre
      • Vellore, India
        • Christian Medical College
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 50008
        • Kamineni Hospitals Pvt, Ltd.
  • United States
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Los Angeles, California, United States, 90017
        • American Institute of Research
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dgd Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
matching placebo
Drug: Metformin
greater than or equal to 1500 mg/kg day
Experimental: MBX-102 400
Drug: MBX-102
capsule
Drug: Metformin
greater than or equal to 1500 mg/kg day
Experimental: MBX-102 600
Drug: MBX-102
capsule
Drug: Metformin
greater than or equal to 1500 mg/kg day
Active Comparator: Actos
30-45 mg
Drug: Metformin
greater than or equal to 1500 mg/kg day
Drug: Actos
over-encapsulated to match MBX-102 and placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in HbA1c from baseline and compared to placebo
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in fasting plasma glucose (FPG) from baseline and vs. placebo
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CymaBay Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 Johns Medical College Hospital, Bangalore, India
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M102-20814

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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