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

This study has been terminated.
(The study was terminated prematurely on 16 May 2014 due to a safety concern.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01792635
First received: December 20, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-05175157
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glucose infusion rates [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Endogenous glucose production [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Endogenous glucose production measured by means of euglycemic hyperinsulinemic clamp

  • Whole-body glucose uptake [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of appearance of glucose in fasting state and during insulin infusions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Glucose infusion rates at steady-state during Step 1 and Step 2 insulin infusions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: December 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Part A (Pilot Study)
Experimental: Monotherapy (Part B) Drug: PF-05175157
PF-05175157 will be administered at 200 mg twice a day for 43 days.
Drug: Placebo
Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792635

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01792635     History of Changes
Other Study ID Numbers: B1731003
Study First Received: December 20, 2012
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Type 2 Diabetes Mellitus
Pharmacodynamics
Safety & Tolerability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014