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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

This study has been completed.
Sponsor:
Information provided by:
CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01035879
First received: December 17, 2009
Last updated: August 18, 2010
Last verified: August 2010

December 17, 2009
August 18, 2010
December 2009
August 2010   (final data collection date for primary outcome 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01035879 on ClinicalTrials.gov Archive Site
Evaluate the effect of MBX-2982 on additional glycemic parameters. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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).

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%.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes
  • Drug: MBX-2982
    tablets and capsule once daily
  • Drug: Sitagliptin
    tablets and capsule once daily
  • Drug: placebo
    tablets and capsule once daily
  • Experimental: MBX-2982 25 mg
    Intervention: Drug: MBX-2982
  • Experimental: MBX-2982 100 mg
    Intervention: Drug: MBX-2982
  • Experimental: MBX-2982 300 mg
    Intervention: Drug: MBX-2982
  • Active Comparator: Sitagliptin 100 mg
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Georgia,   India
 
NCT01035879
M2982-20920
No
Brian Roberts, M.D., Director of Clinical Research, Metabolex
CymaBay Therapeutics, Inc.
Not Provided
Study Director: Brian Roberts, MD Metabolex, Inc.
CymaBay Therapeutics, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP