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:

Metabolex

ClinicalTrials.gov Identifier:

NCT00814372

First received: December 22, 2008

Last updated: February 4, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2008

Last Updated Date

February 4, 2010

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in HbA1c from baseline and compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00814372 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in fasting plasma glucose (FPG) from baseline and vs. placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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%.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: MBX-102
capsule
Drug: Placebo
matching placebo
Drug: Actos
over-encapsulated to match MBX-102 and placebo

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

240

Estimated Completion Date

February 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, India

Administrative Information

NCT Number ^ICMJE

NCT00814372

Other Study ID Numbers ^ICMJE

M102-20814

Has Data Monitoring Committee

Responsible Party

Gopal Saha, Director of Clinical Research, Metabolex, Inc.

Study Sponsor ^ICMJE

Metabolex

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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.

Information Provided By

Metabolex

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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