A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298518
First received: January 28, 2011
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Patients
Drug: PF-04620110
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Insulin at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Net Triglycerides at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
  • Time to Cmax (Tmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
  • Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]

    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.



Enrollment: 48
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04620110 Drug: PF-04620110
5 mg of PF-04620110 given once daily
Drug: PF-04620110
2.5 mg of PF-04620110 given twice daily
Placebo Comparator: placebo Drug: Placebo
Matching placebo giving for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  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: NCT01298518

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
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: NCT01298518     History of Changes
Other Study ID Numbers: B0961007
Study First Received: January 28, 2011
Results First Received: October 5, 2012
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
multiple dose study in type 2 diabetes patients

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

ClinicalTrials.gov processed this record on October 01, 2014