A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

Pfizer

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Patients

Treatments

Drug: Placebo

Drug: PF-04620110

Study type

Interventional

Funder types

Industry

Identifiers

NCT01298518

B0961007

Details and patient eligibility

About

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.

Enrollment

48 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and/or female subjects between the ages of 18 and 60 years;
Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
Subjects who have been on well-tolerated and stable doses of metformin

Exclusion criteria

Recent evidence (6 months prior to screening) or history of unstable major organ disease;
Diagnosis of Type 1 diabetes mellitus;
Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;