Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Placebo for MBX-2044
- Registration Number
- NCT00422487
- Lead Sponsor
- CymaBay Therapeutics, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MBX-2044 1.5 mg MBX-2044 - MBX-2044 60 mg MBX-2044 - MBX-2044 15 mg MBX-2044 - MBX-2044 4.5 mg MBX-2044 - MBX-2044 30 mg MBX-2044 - MBX-2044 90 mg MBX-2044 - Placebo Placebo for MBX-2044 -
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Diabetes and Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States