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A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Chula Vista, California, 91911 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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- Patients with type 2 diabetes mellitus who are taking either no medication for the
treatment of diabetes (diet/exercise therapy only), or who are taking only a single
oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately
8-10 weeks. For those taking a single OAD, treatment should be stable, where this is
defined as no change in the treatment, including dose, over the past 3 months prior to
Screening. OAD medications that are acceptable to be discontinued include: a
sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase
4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.

- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).

- HbA1c >/=7% and =10% if the patient is on diet/exercise therapy only and does not
require any OAD discontinuation. HbA1c >/=6.5% and =9% if the patient requires to be
washed off an OAD.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of diabetic complications with significant end organ damage.

- History of stroke or transient ischemic attack.

- History of myocardial infarction.

- History of coronary artery bypass graft or stent implantation.

- Clinically significant peripheral vascular disease.

- Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.

- Current history of angina/unstable angina.

- One or more episodes of hypoglycemia within the last 3 months, or two or more episodes
of hypoglycemia within the last 6 months.

- A positive urine drug screen.

- Use of tobacco or nicotine-containing products in excess of the equivalent of 10
cigarettes per day.

- Blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic), following at least
5 minutes of rest.

- Pregnant or nursing females; females of childbearing potential.

NCT01469065
Pfizer
Completed
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

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[email protected]

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