A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-05-31

Brief Summary

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This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.

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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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A (Pilot Study)

Group Type NO_INTERVENTION

No interventions assigned to this group

Monotherapy (Part B)

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

PF-05175157 will be administered at 200 mg twice a day for 43 days.

Placebo

Intervention Type DRUG

Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

Interventions

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PF-05175157

PF-05175157 will be administered at 200 mg twice a day for 43 days.

Intervention Type DRUG

Placebo

Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.
* Hemoglobin A1c of ≥7 and ≤10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.
* A waist circumference which makes fitting imto the bore of the MR scanner impossible.

Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No