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

Type 2 Diabetes Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298518
• Other study ID #: B0961007
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2011
• Last updated: October 5, 2012
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Patients

Intervention

Drug:
• PF-04620110
5 mg of PF-04620110 given once daily
• PF-04620110
2.5 mg of PF-04620110 given twice daily
• Placebo
Matching placebo giving for 4 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chula Vista	California
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Miami Gardens	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change From Baseline in Fasting Glucose at Day 28		0 hour (pre-dose) on Day -1, Day 28	No
Secondary	Change From Baseline in Fasting Insulin at Day 28		0 hour (pre-dose) on Day -1, Day 28	No
Secondary	Change From Baseline in Fasting Net Triglycerides at Day 28		0 hour (pre-dose) on Day -1, Day 28	No
Secondary	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	No
Secondary	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	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-04620110		24 hours post-morning dose on Day 28	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110		24 hours post-morning dose on Day 28	No
Secondary	Time to Cmax (Tmax) of PF-04620110		24 hours post-morning dose on Day 28	No
Secondary	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	No

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