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Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
Sponsor: Gilead Sciences
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).
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2008-12
Completion Date
2010-02
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
MBX-102
capsule
Placebo
matching placebo
Actos
over-encapsulated to match MBX-102 and placebo
Metformin
greater than or equal to 1500 mg/kg day
Locations (26)
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