Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus
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.
Interventions
DRUGMBX-2044
MBX-2044 1.5 mg one capsule daily for 14 days
DRUGPlacebo for MBX-2044
Placebo Intervention
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed