Study to Evaluate the Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin - Full Text View

Sponsored by:	Metabolex
Information provided by:	Metabolex
ClinicalTrials.gov Identifier:	NCT00814372

Purpose

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).

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MBX-102 Drug: Placebo Drug: Actos	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Metabolex:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	240
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MBX-102 400: Experimental	Drug: MBX-102 capsule
MBX-102 600: Experimental	Drug: MBX-102 capsule
Placebo: Placebo Comparator	Drug: Placebo matching placebo
Actos: Active Comparator 30-45 mg	Drug: Actos over-encapsulated to match MBX-102 and placebo

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%.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814372

Locations

United States, California
American Institute of Research	Recruiting
Los Angeles, California, United States, 90017
Contact: Michelle Garcia 213-481-7142 mgarcia@airesearch.us
Contact: Ahmed Dessouki 213-481-7142 adessouki@airesearch.us
Principal Investigator: Michael Guice, M.D.
United States, North Carolina
Piedmont Medical Research Associates	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Kristy Felix 336-768-8062 kfelix@pmg-research.com
Contact: Kim Robinson 336-768-8068 krobinson@pmg-research.com
Principal Investigator: Thomas W Littlejohn, M.D
United States, Texas
DGD Research, Inc.	Recruiting
San Antonio, Texas, United States, 78229
Contact: Christiana Adeyemi 210-426-3700 cadeyemi@dgdresearch.com
Contact: Todd Siluk 210-426-3700 tsiluk@dgdresearch.com
Principal Investigator: Sherwyn Schwartz, M.D.

Sponsors and Collaborators

Metabolex

Investigators

Principal Investigator:	Sherwyn Schwartz, 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

More Information

Responsible Party:	Metabolex, Inc. ( Gopal Saha, Director of Clinical Research )
Study ID Numbers:	M102-20814
Study First Received:	December 22, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00814372
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009