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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03985293

Run by

Pfizer

People needed

412

Starts

2019-10-15

Expected to finish

2021-07-07

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Innovative Clinical Research, Inc. — Harbor City, California, United States
• Long Beach Clinical Trials Services, Inc. — Long Beach, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Empire Clinical Research — Pomona, California, United States
• Rancho Cucamonga Clinical Research — Rancho Cucamonga, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Incorporated — Tustin, California, United States
• San Fernando Valley Health Institute, LLC — Van Nuys, California, United States
• Diablo Clinical Research Incorporated — Walnut Creek, California, United States
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• NewPhase Clinical Trials, Corp. — Miami Beach, Florida, United States
• Sunshine Research Center, Inc — Opa-locka, Florida, United States
• Andres Patron D.O. P.A. — Pembroke Pines, Florida, United States
• Ellipsis Group — Alpharetta, Georgia, United States
• East Coast Institute for Research, LLC — Macon, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Buynak Clinical Research — Valparaiso, Indiana, United States
• Viable Research Management LLC — Henderson, Nevada, United States
• Premier Research — Trenton, New Jersey, United States
• PharmQuest — Greensboro, North Carolina, United States
• Holy Trinity Medical Clinic — Harbor City, California, United States

Full record on ClinicalTrials.gov

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