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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: PF-06882961

Study type: Interventional

Funder types: Industry

Identifiers

NCT04552470

C3421015

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-06882961 40 mg

Experimental group

Description:

Participants will be titrated up to 2 weeks to reach desired dose level

Treatment:

Drug: PF-06882961

PF-06882961 80 mg

Experimental group

Description:

Participants will be titrated up to 4 weeks to reach desired dose level

Treatment:

Drug: PF-06882961

PF-06882961 120 mg

Experimental group

Description:

Participants will be titrated up to 6 weeks to reach desired dose level

Treatment:

Drug: PF-06882961