A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2021-03-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Patients with T2DM who are treated with diet and exercise

• HbA1c greater than or equal to 7% and less than or equal to 10.5%

• Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion Criteria:

• Any condition possibly affecting drug absorption

• Diagnosis of Type 1 diabetes

• History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening

• Any malignancy not considered cured

• Personal or family history of MTC or MEN2, or participants with suspected MTC

• Acute pancreatitis or history of chronic pancreatitis

• Symptomatic gallbladder disease

• Known medical history of active proliferative retinopathy and/or macular edema

• Known history of HIV, hepatitis B, hepatitis C or syphilis

• Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)

• Clinically relevant ECG abnormalities

• Positive urine drug test