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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: PF-06882961

Study type: Interventional

Funder types: Industry

Identifiers

NCT03985293

2019-000218-12 (EudraCT Number)

C3421005

Details and patient eligibility

About

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.

Enrollment: 412 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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412 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-06882961 2.5 milligrams (mg)

Experimental group

Treatment:

Drug: PF-06882961

PF-06882961 10 mg

Experimental group

Treatment:

Drug: PF-06882961

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