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

NCT03985293

CompletedPhase 2

Sponsor: Pfizer

Conditions: Diabetes Mellitus, Type 2

Interventions: Placebo, PF-06882961

Countries: United States, Bulgaria, Canada, Hungary, Poland, Slovakia, South Korea, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (83)
  • Harbor City, California, United States
  • Harbor City, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Montclair, California, United States
  • Pomona, California, United States
  • Rancho Cucamonga, California, United States
  • Spring Valley, California, United States
  • Tustin, California, United States
  • Van Nuys, California, United States
  • Walnut Creek, California, United States
  • DeLand, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami Beach, Florida, United States
  • Opa-locka, Florida, United States
  • Pembroke Pines, Florida, United States
  • Alpharetta, Georgia, United States
  • Macon, Georgia, United States
  • Chicago, Illinois, United States
  • Valparaiso, Indiana, United States
  • Henderson, Nevada, United States
  • Trenton, New Jersey, United States
  • Greensboro, North Carolina, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • Edmond, Oklahoma, United States
  • Levittown, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • + 53 more on CT.gov