Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00422487
First received: January 15, 2007
Last updated: September 11, 2007
Last verified: November 2006
  Purpose

The purpose of this study is to collect important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MBX-2044
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of MBX-2044 to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability When Administered Orally in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by CymaBay Therapeutics, Inc.:

Primary Outcome Measures:
  • Evaluate the multiple-dose pharmacokinetics of MBX-2044 administered as monotherapy at the protocol-specified daily dose orally for 14 days
  • Evaluate the clinical safety and tolerability of MBX-2044 after 14 days administration, including the parameters of weight gain and edema
  • Determine the maximum tolerated dose (MTD) of MBX-2044, after 14 days administration
  • Determine the effect of MBX-2044 after 14 days administration, on efficacy parameters

Estimated Enrollment: 50
Study Start Date: October 2006
Study Completion Date: September 2007
Detailed Description:

The current study is designed to test the short-term effectiveness and tolerability of MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin, α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60 mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated for adverse events and vital signs daily. All efficacy and laboratory safety measures will be assessed after 2 weeks. This study will provide important information regarding the glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in diabetics. It will also provide important information about the appropriate doses to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and in combination with other anti-diabetic agents.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes previously controlled with up to one or two non-TZD hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., Prandin®, Starlix®), metformin (e.g., Glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or Byetta®
  • All female patients must be either surgically sterile or post-menopausal.
  • Male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
  • BMI 24-44 kg/m2.
  • Patients must have a FPG ≤ 200 mg/dL at screening.
  • Patients must have Hemoglobin A1c ≥ 6.5%, ≤ 10.0% at screening.
  • Electrocardiogram (ECG) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
  • Patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.

Exclusion Criteria:

  • History of Type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
  • History of TZD use (Actos or Avandia) within 6 months of Screening Visit.
  • History of TZD discontinuation due to lack of efficacy.
  • History of congestive heart failure within last 5 years.
  • History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
  • Malignancy within the last 5 years (except resected basal cell carcinoma).
  • Ongoing active infection.
  • Change in treatment with lipid-lowering agent within 7 days of screening visit.
  • Current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or Plavix® ≤ 75 mg/d].
  • Current or expected treatment with phenytoin for the duration of the study.
  • Known hypersensitivity to NSAIDs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422487

Locations
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
Investigators
Principal Investigator: Sherwyn Schwartz, MD Diabetes and Glandular Research Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422487     History of Changes
Other Study ID Numbers: M2044-20610
Study First Received: January 15, 2007
Last Updated: September 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by CymaBay Therapeutics, Inc.:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014