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

Pfizer1 site in 1 country48 target enrollmentFebruary 2011

ConditionsType 2 Diabetes Patients

InterventionsPF-04620110 Placebo

DrugsPF-04620110 Placebo

Overview

Phase: Phase 1
Intervention: PF-04620110
Conditions: Type 2 Diabetes Patients
Sponsor: Pfizer
Enrollment: 48
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

May 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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;

Arms & Interventions

PF-04620110

Intervention: PF-04620110

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change From Baseline in Fasting Net Triglycerides at Day 28(0 hour (pre-dose) on Day -1, Day 28)
Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28(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(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(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(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(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(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(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 Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28(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(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(24 hours post-morning dose on Day 28)