Diabetes
Conditions
Brief 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).
Detailed description
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
Interventions
DRUGMBX-2982
tablets and capsule once daily
DRUGSitagliptin
tablets and capsule once daily
DRUGplacebo
tablets and capsule once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effect of MBX-2982 on additional glycemic parameters. | 4 weeks |
Countries
Georgia, India, United States
Outcome results
None listed