A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
- Registration Number
- NCT01298518
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04620110 PF-04620110 - placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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 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 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 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 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 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 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Miami Gardens, Florida, United States