Conditions: Diabetes Mellitus, Type 2
Keywords: inpatient diabetes phase 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief summary:
This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.

Detailed description:

Arms:
arm 1: PF-04991532 experimental study medication arm 2: PF-04991532 Matching Placebo

Interventions: intervention 1: PF-04991532 intervention 2: PF-04991532 intervention 3: PF-04991532 intervention 4: PF-0499132 intervention 5: Placebo
Intervention descriptions: intervention 1: Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days intervention 2: Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days intervention 3: Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days intervention 4: Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days intervention 5: Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days

Protocol document: