Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
Brief summary
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.
Interventions
DRUGPlacebo
Matching placebo of 100 mg BID
DRUGINCB013739
INCB013739 100 mg BID
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Have an established diagnosis of Type 2 Diabetes as determined by the investigator. 2. Females will be postmenopausal for at least 1 year with documented FSH \> 30 IU/L.
Exclusion criteria
1. Hypertriglyceridemia \> 500 mg/dL at screening. 2. BMI \> 40 kg/m2. 3. Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening. 4. History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids. 5. Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lipid profile laboratory values | Measured at baseline and weekly for four weeks |
| Assessment of pharmacokinetics of INCB013739 through analysis of blood samples. | Measured at baseline and weekly for four weeks |
| Assessment of pharmacodynamics of INCB013739 through analysis of blood samples | Measured at baseline and weekly for four weeks |
| Assessment of ECGs, physical examinations and laboratory values for adverse events | Measured at baseline through study completion |
Countries
United States
Outcome results
None listed