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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: MBX-2982; Drug: Sitagliptin; Drug: placebo

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%.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0144
    • Healthy Life Clinical Diagnostic Center
  • Tbilisi, Georgia, 0159
    • Georgian Diabetes Center
  • Tbilisi, Georgia, 0186
    • Medulla Chemotherapy and Immunotherapy Clinic
• India
  • Bangalore, India, 560 054
    • Gokula Metropolis Research, MS Ramaiah Memorial Hospital
  • Bangalore, India, 560043
    • Medisys Clinisearch India Pvt Ltd
  • Ghaziabad, India, 201002
    • Hormone Care Research Centre
  • Malleshwaram, India, 560 003
    • Bangalore Endocrinology & Diabetes Research Centre
  • Haryana
    • Karnal, Haryana, India, 132001
      • Bharti Research Institute of Diabetes and Endocrinology
  • M.p.
    • Indore, M.p., India, 452001
      • Diabetes Thyroid Hormone Research Institute PVT LTD
  • Nagpur
    • Ramdaspeth, Nagpur, India, 10
      • Gandhi Endocrinology & Diabetes Centre
• United States
  • California
    • Los Angeles, California, United States, 90036
      • Impact Clinical Trials
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Nevada Alliance Against Diabetes
  • New York
    • Binghamton, New York, United States, 13901
      • United Medical Associates
  • Texas
    • San Antonio, Texas, United States, 78229
      • dgd Research, Inc., a Cetero Research Co.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: CymaBay Therapeutics, Inc.
• Investigators: Study Director: Brian Roberts, MD, Metabolex, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: M2982-20920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No