A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Key facts

Study ID

NCT02554877

Run by

Pfizer

People needed

206

Starts

2015-10-01

Expected to finish

2016-08-01

Last updated by the study team

2017-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential
• Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
• HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)

You may not qualify if…

• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
• Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary
• History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;
• Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
• Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary
• Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
• Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements
• Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility
• Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
• History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);
• Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
• Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• National Research Institute — Los Angeles, California, United States
• NRC Research Institute — Orange, California, United States
• Sierra Clinical Research — Roseville, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Empire Clinical Research — Upland, California, United States
• Diablo Clinical Research, Inc — Walnut Creek, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Suncoast Research Group, Llc — Miami, Florida, United States
• QPS-MRA, LLC (Miami Research Associates) — South Miami, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• WR-Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Crescent City Clinical Research Center, LLC — Metairie, Louisiana, United States
• St. Louis Clinical Trials, LC — St Louis, Missouri, United States
• ALAS Science Clinical Research — Las Vegas, Nevada, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Clinilabs Inc. — Eatontown, New Jersey, United States
• Pharmaceutical Research Associates, Inc. — Marlton, New Jersey, United States
• TLB Research — Trenton, New Jersey, United States
• Randolph Medical Associates — Asheboro, North Carolina, United States
• High Point Clinical Trials Center, LLC — High Point, North Carolina, United States
• Lillestol Research, LLC — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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