Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

Group Type EXPERIMENTAL

PF-05231023

Intervention Type DRUG

5 mg IV twice a week for 4 weeks

PF-05231023

Intervention Type DRUG

25 mg IV twice a week for 4 weeks

PF-05231023

Intervention Type DRUG

100 mg IV twice a week for 4 weeks

PF-05231023

Intervention Type DRUG

200 mg IV twice a week for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks

Interventions

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PF-05231023

5 mg IV twice a week for 4 weeks

Intervention Type DRUG

PF-05231023

25 mg IV twice a week for 4 weeks

Intervention Type DRUG

PF-05231023

100 mg IV twice a week for 4 weeks

Intervention Type DRUG

PF-05231023

200 mg IV twice a week for 4 weeks

Intervention Type DRUG

Placebo

0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male subjects and female subjects of non-childbearing potential between the ages of 30 and 70 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines. Subjects who have other conditions but are well controlled by either diet or medications may be included as well (for example, a subject with high cholesterol level on appropriate treatment is eligible).
* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs).

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No