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Trial record 1 of 1 for:    NCT02053103
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A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin

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ClinicalTrials.gov Identifier: NCT02053103
Recruitment Status : Terminated (On 25April2014, study was terminated before any dosing due to an AE of safety concern that occurred in protocol B1731003 with the same drug.)
First Posted : February 3, 2014
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 30, 2014
First Posted Date  ICMJE February 3, 2014
Last Update Posted Date May 2, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo [ Time Frame: Baseline, Day 42 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo [ Time Frame: Weeks 0 and 4 ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Weeks 0, 2, 4 and 6 ]
  • Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in fasting total cholesterol [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in homeostatic model assessment for β-cell function (HOMA B) [ Time Frame: Weeks 0, 4 and 6 ]
  • Plasma concentrations for PF-05175157 [ Time Frame: Weeks 2, 4 and 6 ]
  • Percent change from baseline in body weight [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in high density lipoprotein cholesterol (HDL-C) [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in triglycerides [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in non-HDL cholesterol [ Time Frame: Weeks 0, 4 and 6 ]
  • Change from baseline in very low density lipoprotein (VLDL) [ Time Frame: Weeks 0, 4 and 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin
Official Title  ICMJE A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-05175157
    Tablet, 200 mg, twice daily, 6 weeks
  • Drug: Placebo
    Tablet, 0 mg, twice daily, 6 weeks
Study Arms  ICMJE
  • Experimental: PF-05175157
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
60
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
  • Hemoglobin A1c of 7-10% at screening.
  • Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

  • Compliant with study drug administration during the run-in period and throughout the trial.
  • Patients with fasting triglycerides greater than 500 mg/dL at screening.
  • History of certain diabetic complications or cardiac problems.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02053103
Other Study ID Numbers  ICMJE B1731002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2014

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