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

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CymaBay Therapeutics

Status and phase

Completed
Phase 2

Conditions

Diabetes

Treatments

Drug: placebo
Drug: MBX-2982
Drug: Sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01035879
M2982-20920

Details and patient eligibility

About

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).

Full 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%.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 5 patient groups, including a placebo group

MBX-2982 25 mg
Experimental group
Treatment:
Drug: MBX-2982
MBX-2982 100 mg
Experimental group
Treatment:
Drug: MBX-2982
MBX-2982 300 mg
Experimental group
Treatment:
Drug: MBX-2982
Sitagliptin 100 mg
Active Comparator group
Treatment:
Drug: Sitagliptin
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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