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

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

MBX-102

capsule

DRUG

Placebo

matching placebo

DRUG

Actos

over-encapsulated to match MBX-102 and placebo

DRUG

Metformin

greater than or equal to 1500 mg/kg day

Sponsors & Collaborators

• Gilead Sciences

  lead INDUSTRY

Principal Investigators

• Douglas Denham, M.D. · dgd Research, Inc.

• Thomas W. Littlejohn, M.D. · Piedmont Medical Research Associates

• Michael Guice, M.D. · American Institute of Research

• K. M. Prasanna Kumar, MD · M. S. Ramaiah Memorial Hospital

• Veerasamy Seshiah, MD · Dr. V. Seshiah Diabetes Care & Research Institute

• Sanjay Kalra, MD · Bharti Research Institute of Diabetes & Endocrinology

• Sailesh Lodha, MD · Fortis Hospital

• Ariachery C Ammini, MD · All India Institute of Medical Sciences

• Prema Varthakavi, MD · BYL Nair Hospital

• Sanjiv Shah, MD · Diabetes Action Centre

• Manoj Chadha, MD · PD Hindhuja National Hospital & Medical Research Centre

• Mathew Thomas, MD · Health & Research Centre

• Sanjay Reddy, MD · Bangalore Diabetes Centre

• Ganapati Bantwal, MD · St Johns Medical College Hospital, Bangalore, India

• Aravind S Sosale, MD · Diacon Hospital Diabetes & Research Centre

• Vaishali Deshmukh, MD · Deenanath Mangeshkar Hospital & Research Centre

• Abhay Mutha, MD · Diabetes Care & Research Centre

• Nihal Thomas, MD · Christian Medical College, Vellore, India

• Kirtikumar Modi, MD · Medwin Hospital

• Sunil Jain, MD · Diabetes Thyroid Hormone Research Institute Pvt. Ltd.

• Pramod Gandhi, MD · Gandhi Endocrinology & Diabetes Centre

• Rakesh Kumar Sahay, MD · Mediciti Hospital

• Harish Kumar, MD · Amrita Institute of Medical Sciences

• Rubin Savedra, MD · Association of International Professionals, dba Nevada Alliance Against Diabetes

• Teresa Sligh, MD · Translational Research Group, Inc. dba Providence Clinical Research

• Prabha Adhikari, MD · Kasturba Medical College Hospital

• Navneet Agrawal, MD · Diabetes, Obesity and Thyroid Center

• Swamy Miryala, MD · Kamineni Hospitals Pvt, Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2010-02-28

Completion

2010-02-28

Countries

• United States
• India

Study Locations