NCT01129258

Multiple Dose Study of PF-04991532 in Patients With Type 2 Diabetes

A Phase 1 Placebo-Controlled Trial to Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses of PF-04991532 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04991532 following multiple (14 days) escalating oral doses in patient wtih type 2 diabetes.

Detailed description

Safety/Tolerability, PK, and PD

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	PF-04991532	Subjects will be dosed wtih PF-04991532 for 14 days. The tentative dosing schedule is 30, 100, 300, 1000, and 1500 mg QD, and 150 and 500 mg BID). Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as tablets (10, 50, and 150 mg strengths). In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
DRUG	Placebo	Placebo to match PF-04991532 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-05-24
• Last updated: 2011-03-09

Locations

4 sites across 1 country: United States