Status:
COMPLETED
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
Lead Sponsor:
Gilead Sciences
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 al...
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 hypogl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00422487
Start Date
October 1 2006
End Date
September 1 2007
Last Update
May 1 2015
Active Locations (1)
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1
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801