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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01792635
First received: December 20, 2012
Last updated: May 17, 2013
Last verified: May 2013
History of Changes

December 20, 2012
May 17, 2013
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 ]
  • 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 And In Combination With Metformin 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 and in combination with metformin 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 100 mg bid for 42 days
  • Drug: Placebo
    Matched placebo will be administered bid for 42 days.
  • No Intervention: Part A (Pilot Study)
  • Experimental: Monotherapy
    Interventions:
    • Drug: PF-05175157
    • Drug: Placebo
  • Experimental: Metforming Combination Therapy
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Metformin Combination Therapy
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
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 on metformin monotherapy (≥1000 mg per day)
  • Hemoglobin A1c of ≥6.5 and ≤9.5% in subjects who are metformin-naïve or discontinued metformin more than 4 months prior to screening

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.
  • Evidence or history of any chronic ongoing or current pulmonary disease.
  • History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -5.
Both
18 Years to 65 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT01792635
B1731003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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