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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01285518

Run by

Pfizer

People needed

84

Starts

2011-02-01

Expected to finish

2011-07-01

Last updated by the study team

2016-11-18

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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.

Where it is running

• Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
• Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) — Fort Meyers, Florida, United States
• Elite Research Institute — Miami, Florida, United States
• Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) — Miramar, Florida, United States
• Cetero Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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