NCT01298518CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: PF-04620110 (Drug)
placebo
Placebo Comparator
Intervention: Placebo (Drug)
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)
Investigators
Study Sites (1)
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