Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluate the effect of MBX-2982 on additional glycemic parameters.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Las Vegas
country: United States
facility: Nevada Alliance Against Diabetes
state: Nevada
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: San Antonio
country: United States
facility: dgd Research, Inc., a Cetero Research Co.
state: Texas
city: Tbilisi
country: Georgia
facility: Healthy Life Clinical Diagnostic Center
city: Tbilisi
country: Georgia
facility: Georgian Diabetes Center
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Karnal
country: India
facility: Bharti Research Institute of Diabetes and Endocrinology
state: Haryana
city: Indore
country: India
facility: Diabetes Thyroid Hormone Research Institute Pvt Ltd
state: M.p.
city: Ramdaspeth
country: India
facility: Gandhi Endocrinology & Diabetes Centre
state: Nagpur
city: Bangalore
country: India
facility: Gokula Metropolis Research, MS Ramaiah Memorial Hospital
city: Bangalore
country: India
facility: Medisys Clinisearch India Pvt Ltd
city: Ghaziabad
country: India
facility: Hormone Care Research Centre
city: Malleshwaram
country: India
facility: Bangalore Endocrinology & Diabetes Research Centre
Study officials:
affiliation: Metabolex, Inc.
name: Brian Roberts, MD
role: STUDY_DIRECTOR
References: