At a glance
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A 2-week, Phase 1, Placebo-Controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Oral Doses Of PF-04991532 Given As Monotherapy To Adult Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating PF-04991532, PF-0499132, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 82 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days