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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CymaBay Therapeutics, Inc.

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.