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

• Status: Recruiting
• Trial end date: 2022-01-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.

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

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment

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

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

Exclusion Criteria:

• Any condition possibly affecting drug absorption

• Diagnosis of Type 1 diabetes mellitus or secondary forms of 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

• Acute gallbladder disease

• Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them

• 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

• Clinical relevant laboratory tests abnormalities