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

Study Overview
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Brief Summary
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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
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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%.

Official Title
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Phase 2, Randomized, Double-Blind, Placebo and Active-Comparator Controlled 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
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Diabetes

Intervention / Treatment
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* Drug: MBX-2982
* Drug: MBX-2982
* Drug: MBX-2982
* Drug: Sitagliptin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBX-2982 25 mg<br> | Drug: MBX-2982<br>* tablets and capsule once daily<br>|
| Experimental: MBX-2982 100 mg<br> | Drug: MBX-2982<br>* tablets and capsule once daily<br>|
| Experimental: MBX-2982 300 mg<br> | Drug: MBX-2982<br>* tablets and capsule once daily<br>|
| Active Comparator: Sitagliptin 100 mg<br> | Drug: Sitagliptin<br>* tablets and capsule once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* tablets and capsule once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of MBX-2982 on additional glycemic parameters. |  | 4 weeks |