Clinical trial NCT01298518: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Patients
Keywords: multiple dose study in type 2 diabetes patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
Secondary outcomes:
measure: Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28
timeFrame: Baseline (Day -1); 24 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28
measure: Change From Baseline in Fasting Glucose at Day 28
timeFrame: 0 hour (pre-dose) on Day -1, Day 28
measure: Change From Baseline in Fasting Insulin at Day 28
timeFrame: 0 hour (pre-dose) on Day -1, Day 28
measure: Change From Baseline in Fasting Net Triglycerides at Day 28
timeFrame: 0 hour (pre-dose) on Day -1, Day 28
measure: 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
timeFrame: Baseline (Day -1); 6 to 10 hours post-dose on Day 28
measure: 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
timeFrame: Baseline (Day -1); 12 to 16 hours post-dose on Day 28
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04620110
timeFrame: 24 hours post-morning dose on Day 28
measure: Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110
timeFrame: 24 hours post-morning dose on Day 28
measure: Time to Cmax (Tmax) of PF-04620110
timeFrame: 24 hours post-morning dose on Day 28
measure: Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110
timeFrame: 24 hours post-morning dose on Day 28
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: