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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: PF-0499132; Drug: PF-04991532

Study type: Interventional

Funder types: Industry

Identifiers

NCT01469065

B2611005

Details and patient eligibility

About

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 works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

PF-04991532

Experimental group

Description:

PF-04991532 experimental study medication

Treatment:

Drug: PF-0499132

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Placebo

Placebo Comparator group

Description:

PF-04991532 Matching Placebo

Treatment:

Drug: Placebo