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Trial record 1 of 1 for:    NCT01298518
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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT01298518
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : November 6, 2012
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 28, 2011
First Posted Date  ICMJE February 17, 2011
Results First Submitted Date  ICMJE October 5, 2012
Results First Posted Date  ICMJE November 6, 2012
Last Update Posted Date November 6, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
To evaluate the pharmacodynamic markers in response to multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT01298518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
  • Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 [ Time Frame: Baseline (Day -1); 24 hours post-dose on Day 28 ]
    APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
  • Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
  • Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
  • Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ]
    Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
  • Change From Baseline in Fasting Glucose at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
  • Change From Baseline in Fasting Insulin at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
  • Change From Baseline in Fasting Net Triglycerides at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ]
  • Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 [ Time Frame: Baseline (Day -1); 6 to 10 hours post-dose on Day 28 ]
    Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
  • Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 [ Time Frame: Baseline (Day -1); 12 to 16 hours post-dose on Day 28 ]
    Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
  • Maximum Observed Plasma Concentration (Cmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
  • Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
  • Time to Cmax (Tmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
  • Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ]
    Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours. AUC (0-24) was computed using the linear trapezoidal method.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • To evaluate secondary Pharmacodynamic Endpoints in response to multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
  • To characterize the PK of PF-04620110 following multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
  • To assess safety and tolerability of PF-04620110 following multiple oral doses of PF-04620110 in T2DM patients [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Official Title  ICMJE A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin
Brief Summary PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Patients
Intervention  ICMJE
  • Drug: PF-04620110
    5 mg of PF-04620110 given once daily
  • Drug: PF-04620110
    2.5 mg of PF-04620110 given twice daily
  • Drug: Placebo
    Matching placebo giving for 4 weeks
Study Arms  ICMJE
  • Experimental: PF-04620110
    Interventions:
    • Drug: PF-04620110
    • Drug: PF-04620110
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2011)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and/or female subjects between the ages of 18 and 60 years;
  • Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
  • Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
  • Subjects who have been on well-tolerated and stable doses of metformin

Exclusion Criteria:

  • Recent evidence (6 months prior to screening) or history of unstable major organ disease;
  • Diagnosis of Type 1 diabetes mellitus;
  • Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
  • Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01298518
Other Study ID Numbers  ICMJE B0961007
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 October 2012

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