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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035879
• Other study ID #: M2982-20920
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2009
• Last updated: March 30, 2015
• Start date: December 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2015
• Source: CymaBay Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaGeorgia: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• MBX-2982
tablets and capsule once daily
• MBX-2982
tablets and capsule once daily
• MBX-2982
tablets and capsule once daily
• Sitagliptin
tablets and capsule once daily
• placebo
tablets and capsule once daily

Locations

Country	Name	City	State
Georgia	Georgian Diabetes Center	Tbilisi
Georgia	Healthy Life Clinical Diagnostic Center	Tbilisi
Georgia	Medulla Chemotherapy and Immunotherapy Clinic	Tbilisi
India	Gokula Metropolis Research, MS Ramaiah Memorial Hospital	Bangalore
India	Medisys Clinisearch India Pvt Ltd	Bangalore
India	Hormone Care Research Centre	Ghaziabad
India	Diabetes Thyroid Hormone Research Institute Pvt Ltd	Indore	M.p.
India	Bharti Research Institute of Diabetes and Endocrinology	Karnal	Haryana
India	Bangalore Endocrinology & Diabetes Research Centre	Malleshwaram
India	Gandhi Endocrinology & Diabetes Centre	Ramdaspeth	Nagpur
United States	United Medical Associates	Binghamton	New York
United States	Nevada Alliance Against Diabetes	Las Vegas	Nevada
United States	Impact Clinical Trials	Los Angeles	California
United States	dgd Research, Inc., a Cetero Research Co.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CymaBay Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Georgia,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate the effect of MBX-2982 on additional glycemic parameters.		4 weeks	Yes