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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Patients
• Intervention / Treatment: Drug: PF-04620110; Drug: PF-04620110; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Pfizer Investigational Site
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site
    • Miami Gardens, Florida, United States, 33169
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; Matching placebo giving for 4 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day -1); 24 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
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.	Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Change From Baseline in Fasting Glucose at Day 28		0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Insulin at Day 28		0 hour (pre-dose) on Day -1, Day 28
Change From Baseline in Fasting Net Triglycerides at Day 28		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	Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.	Baseline (Day -1); 6 to 10 hours post-dose on Day 28
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.	Baseline (Day -1); 12 to 16 hours post-dose on Day 28
Maximum Observed Plasma Concentration (Cmax) of PF-04620110		24 hours post-morning dose on Day 28
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110		24 hours post-morning dose on Day 28
Time to Cmax (Tmax) of PF-04620110		24 hours post-morning dose on Day 28
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.	24 hours post-morning dose on Day 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: October 5, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: multiple dose study in type 2 diabetes patients
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: B0961007