Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-05231023; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01285518

B2901001

Details and patient eligibility

About

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.

Enrollment: 84 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
• Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
• HbA1c >7% and not to exceed 10.5%.

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).
• Diagnosis of Type 1 diabetes mellitus
• Evidence of diabetic complications with significant end organ damage.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Treatment:

Drug: PF-05231023

Drug: PF-05231023

Drug: PF-05231023

Drug: PF-05231023

Drug: PF-05231023

Drug: PF-05231023

Drug: PF-05231023

Placebo

Placebo Comparator group

Description:

0.9% w/v sodium chloride injection, USP

Treatment:

Other: Placebo