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

NCT ID: NCT00814372

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-02-28

Brief 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).

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%.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MBX-102 400

Group Type: EXPERIMENTAL

MBX-102

Intervention Type: DRUG

capsule

Metformin

Intervention Type: DRUG

greater than or equal to 1500 mg/kg day

MBX-102 600

Group Type: EXPERIMENTAL

MBX-102

Intervention Type: DRUG

capsule

Metformin

Intervention Type: DRUG

greater than or equal to 1500 mg/kg day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo

Metformin

Intervention Type: DRUG

greater than or equal to 1500 mg/kg day

Actos

30-45 mg

Group Type: ACTIVE_COMPARATOR

Actos

Intervention Type: DRUG

over-encapsulated to match MBX-102 and placebo

Metformin

Intervention Type: DRUG

greater than or equal to 1500 mg/kg day

Interventions

MBX-102

capsule

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Actos

over-encapsulated to match MBX-102 and placebo

Intervention Type: DRUG

Metformin

greater than or equal to 1500 mg/kg day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Denham, M.D.

Role: PRINCIPAL_INVESTIGATOR

dgd Research, Inc.

Thomas W. Littlejohn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Piedmont Medical Research Associates

Michael Guice, M.D.

Role: PRINCIPAL_INVESTIGATOR

American Institute of Research

K. M. Prasanna Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

M. S. Ramaiah Memorial Hospital

Veerasamy Seshiah, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. V. Seshiah Diabetes Care & Research Institute

Sanjay Kalra, MD

Role: PRINCIPAL_INVESTIGATOR

Bharti Research Institute of Diabetes & Endocrinology

Sailesh Lodha, MD

Role: PRINCIPAL_INVESTIGATOR

Fortis Hospital

Ariachery C Ammini, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Prema Varthakavi, MD

Role: PRINCIPAL_INVESTIGATOR

BYL Nair Hospital

Sanjiv Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Action Centre

Manoj Chadha, MD

Role: PRINCIPAL_INVESTIGATOR

PD Hindhuja National Hospital & Medical Research Centre

Mathew Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Health & Research Centre

Sanjay Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Bangalore Diabetes Centre

Ganapati Bantwal, MD

Role: PRINCIPAL_INVESTIGATOR

St Johns Medical College Hospital, Bangalore, India

Aravind S Sosale, MD

Role: PRINCIPAL_INVESTIGATOR

Diacon Hospital Diabetes & Research Centre

Vaishali Deshmukh, MD

Role: PRINCIPAL_INVESTIGATOR

Deenanath Mangeshkar Hospital & Research Centre

Abhay Mutha, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care & Research Centre

Nihal Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Kirtikumar Modi, MD

Role: PRINCIPAL_INVESTIGATOR

Medwin Hospital

Sunil Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Thyroid Hormone Research Institute Pvt. Ltd.

Pramod Gandhi, MD

Role: PRINCIPAL_INVESTIGATOR

Gandhi Endocrinology & Diabetes Centre

Rakesh Kumar Sahay, MD

Role: PRINCIPAL_INVESTIGATOR

Mediciti Hospital

Harish Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Amrita Institute of Medical Sciences

Rubin Savedra, MD

Role: PRINCIPAL_INVESTIGATOR

Association of International Professionals, dba Nevada Alliance Against Diabetes

Teresa Sligh, MD

Role: PRINCIPAL_INVESTIGATOR

Translational Research Group, Inc. dba Providence Clinical Research

Prabha Adhikari, MD

Role: PRINCIPAL_INVESTIGATOR

Kasturba Medical College Hospital

Navneet Agrawal, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes, Obesity and Thyroid Center

Swamy Miryala, MD

Role: PRINCIPAL_INVESTIGATOR

Kamineni Hospitals Pvt, Ltd.

Locations

Providence Clinical Research

Burbank, California, United States

American Institute of Research

Los Angeles, California, United States

Nevada Alliance Against Diabetes

Las Vegas, Nevada, United States

Piedmont Medical Research Associates

Winston-Salem, North Carolina, United States

DGD Research, Inc.

San Antonio, Texas, United States

Kamineni Hospitals Pvt, Ltd.

Hyderabad, Andhra Pradesh, 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

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

Karnāl, , India

Amrita Institute of Medical Sciences

Kochi, , India

Diabetes Action Centre

Mumbai, , India

BYL Nair Hospital

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, , India

Countries

United States; India

Other Identifiers

M102-20814

Identifier Type: -

Identifier Source: org_study_id