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

NCT00814372 | Terminated Phase 2

• 1 other identifier: M102-20814
• Study Type: interventional
• Target: 242
• Locations: 2 countries
• Sites: 26

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline and compared to placebo

  24 weeks

Secondary Outcomes (1)

• Change in fasting plasma glucose (FPG) from baseline and vs. placebo

  24 weeks

Study Arms (4)

MBX-102 400

EXPERIMENTAL

Drug: MBX-102; Drug: Metformin

MBX-102 600

EXPERIMENTAL

Drug: MBX-102; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Metformin

Actos

ACTIVE COMPARATOR

30-45 mg

Drug: Actos; Drug: Metformin

Interventions

MBX-102 DRUG

capsule

MBX-102 400; MBX-102 600

Placebo DRUG

matching placebo

Placebo

Actos DRUG

over-encapsulated to match MBX-102 and placebo

Actos

Metformin DRUG

greater than or equal to 1500 mg/kg day

Actos; MBX-102 400; MBX-102 600; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (26)

Providence Clinical Research

Burbank, California, 91505, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

Nevada Alliance Against Diabetes

Las Vegas, Nevada, 89101, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

DGD Research, Inc.

San Antonio, Texas, 78229, United States

Location

Kamineni Hospitals Pvt, Ltd.

Hyderabad, Andhra Pradesh, 50008, India

Location

Bangalore Diabetes Centre

Bangalore, India

Location

Diacon Hospital Diabetes & Research Centre

Bangalore, India

Location

M. S. Ramaiah Memorial Hospital

Bangalore, India

Location

St. John's Medical College & Hospital

Bangalore, India

Location

Dr. V. Seshiah Diabetes Care & Research Institute

Chennai, India

Location

Mediciti Hospital

Hyderabad, India

Location

Medwin Hospital

Hyderabad, India

Location

Diabetes Thyroid Hormone Research Institute Pvt. Ltd.

Indore, India

Location

Fortis Hospital

Jaipur, India

Location

Bharti Research Institute of Diabetes & Endocrinology

Karnāl, India

Location

Amrita Institute of Medical Sciences

Kochi, India

Location

Diabetes Action Centre

Mumbai, 400067, India

Location

BYL Nair Hospital

Mumbai, India

Location

PD Hindhuja National Hospital

Mumbai, India

Location

Gandhi Endocrinology & Diabetes Centre

Nagpur, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, India

Location

Diabetes Care & Research Centre

Pune, India

Location

Health & Research Centre

Trivendrum, India

Location

Christian Medical College

Vellore, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

arhalofenate; Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• 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

  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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 17, 2015

Record last verified: 2015-03

Locations

IN (21); US (5)