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Completed
NCT01035879
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
Conditions: Diabetes
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: Gilead Sciences
Location: Impact Clinical Trials Los Angeles California
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT01035879). StuddyBuddy aggregates publicly available trial information.