Status:
COMPLETED
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01469065
Start Date
December 1 2011
End Date
May 1 2012
Last Update
October 30 2013
Active Locations (3)
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1
Pfizer Investigational Site
Chula Vista, California, United States, 91911
2
Pfizer Investigational Site
Miami, Florida, United States, 33169
3
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan