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

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Pfizer

Status and phase

Terminated
Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo
Drug: PF-05175157

Study type

Interventional

Funder types

Industry

Identifiers

NCT01792635
B1731003

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

19 participants in 2 patient groups

Part A (Pilot Study)
No Intervention group
Monotherapy (Part B)
Experimental group
Treatment:
Drug: PF-05175157
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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