Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: PF-04603629; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638313

B0571001

Details and patient eligibility

About

PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.

Enrollment: 71 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Hb A1c lower or equal to 11%

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).
• Evidence of diabetic complications with significant end-organ damage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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71 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

PF-04603629

Experimental group

Treatment:

Biological: PF-04603629