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

Primary Purpose

Type 2 Diabetes Patients

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04620110
PF-04620110
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Patients focused on measuring multiple dose study in type 2 diabetes patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04620110

placebo

Arm Description

Outcomes

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
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
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
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
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
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
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
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
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
Change From Baseline in Fasting Insulin at Day 28
Change From Baseline in Fasting Net Triglycerides at 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
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
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
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
Time to Cmax (Tmax) of PF-04620110
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
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.

Full Information

First Posted
January 28, 2011
Last Updated
October 5, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01298518
Brief Title
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Patients
Keywords
multiple dose study in type 2 diabetes patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04620110
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04620110
Intervention Description
5 mg of PF-04620110 given once daily
Intervention Type
Drug
Intervention Name(s)
PF-04620110
Intervention Description
2.5 mg of PF-04620110 given twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo giving for 4 weeks
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
Description
APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
Time Frame
Baseline (Day -1); 24 hours post-dose on Day 28
Title
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
Description
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.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
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
Description
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.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
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
Description
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.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
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
Description
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.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
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
Description
Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
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
Description
Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
Time Frame
Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Title
Change From Baseline in Fasting Glucose at Day 28
Time Frame
0 hour (pre-dose) on Day -1, Day 28
Title
Change From Baseline in Fasting Insulin at Day 28
Time Frame
0 hour (pre-dose) on Day -1, Day 28
Title
Change From Baseline in Fasting Net Triglycerides at Day 28
Time Frame
0 hour (pre-dose) on Day -1, Day 28
Title
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
Description
Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Time Frame
Baseline (Day -1); 6 to 10 hours post-dose on Day 28
Title
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
Description
Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
Time Frame
Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Title
Maximum Observed Plasma Concentration (Cmax) of PF-04620110
Time Frame
24 hours post-morning dose on Day 28
Title
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
Time Frame
24 hours post-morning dose on Day 28
Title
Time to Cmax (Tmax) of PF-04620110
Time Frame
24 hours post-morning dose on Day 28
Title
Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
Description
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.
Time Frame
24 hours post-morning dose on Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0961007&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-04620110%20In%20Type%202%20Diabetes%20Patients
Description
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A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients

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