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

Last updated on March 15, 2019

Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. 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

2. Subjects who have been on a stable dose of metformin either alone or in combination
with one additional acceptable OAD

3. 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)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;

2. 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

3. 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;

4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any
area of intestinal resection, active inflammatory bowel disease or pancreatic

5. Subjects with a creatinine clearance equation (listed below) using serum creatinine measured at screening, confirmed via a
single repeat, if deemed necessary

6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B
core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies

7. 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

8. 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

9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of
the upper arm;

10. 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);

11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic
agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;

12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor
antagonist, or known prior participation in a trial involving PF 06291874;

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


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