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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

December 20, 2012
July 2, 2014
December 2012
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01792635 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • 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.
  • No Intervention: Part A (Pilot Study)
  • Experimental: Monotherapy (Part B)
    Interventions:
    • Drug: PF-05175157
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
May 2014
May 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01792635
B1731003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP