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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

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Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
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
potential

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
insufficiency

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
measurements

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;

NCT02554877
Pfizer
Completed
A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

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Pfizer Clinical Trials Contact Center

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[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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