Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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).
Key facts
- Study ID
- NCT00814372
- Run by
- Gilead Sciences
- People needed
- 242
- Starts
- 2008-12-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2015-04-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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