Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes
In brief
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
Key facts
- Study ID
- NCT01035879
- Run by
- Gilead Sciences
- People needed
- 100
- Starts
- 2009-12-01
- Expected to finish
- 2010-08-01
- 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…
- History of type 2 diabetes of at least 3 months duration
- Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
- HbA1c 7.0-8.5% (inclusive) at screening
- BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India
You may not qualify if…
- Any history of type 1 diabetes or diabetic ketoacidosis
- History of major upper GI surgery
- Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
- History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
Where it is running
- Impact Clinical Trials — Los Angeles, California, United States
- Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
- United Medical Associates — Binghamton, New York, United States
- dgd Research, Inc., a Cetero Research Co. — San Antonio, Texas, United States
- Healthy Life Clinical Diagnostic Center — Tbilisi, Georgia
- Georgian Diabetes Center — Tbilisi, Georgia
- Medulla Chemotherapy and Immunotherapy Clinic — Tbilisi, Georgia
- Bharti Research Institute of Diabetes and Endocrinology — Karnāl, Haryana, India
- Diabetes Thyroid Hormone Research Institute Pvt Ltd — Indore, M.p., India
- Gandhi Endocrinology & Diabetes Centre — Rāmdaspeth, Nagpur, India
- Gokula Metropolis Research, MS Ramaiah Memorial Hospital — Bangalore, India
- Medisys Clinisearch India Pvt Ltd — Bangalore, India
- Hormone Care Research Centre — Ghaziabad, India
- Bangalore Endocrinology & Diabetes Research Centre — Malleshwaram, India
Full record on ClinicalTrials.gov
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