A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2021-07-07
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Patients with T2DM who are treated with metformin and/or 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 24.5 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 medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis

• Known history of HIV

• 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