Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes

Pfizer

Status and phase

Completed

Phase 1

Conditions

NIDDM

Diabetes Mellitus, Type 2

Treatments

Drug: PF-04937319

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01272804

B1621003

Details and patient eligibility

About

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.

Enrollment

61 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with type 2 diabetes mellitus who are taking metformin only.
Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.
Male and/or female patients (females will be women of non childbearing potential)
Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
HbA1c between 7.0% and 10.0%.

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible).
Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min
Any condition possibly affecting drug absorption (eg, gastrectomy)
History of stroke or transient ischemic attack or myocardial infarction within the past 6 months
History of coronary artery bypass graft or stent implantation.
Clinically significant peripheral vascular disease (eg, manifested by claudication).
Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.
One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months.
Current history of angina/unstable angina.
Milk or soy allergy