Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1b, Randomized, Double-Blind, Active Comparator Controlled, 3-Period, Cross-Over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of PF-04937319 In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933672
• Other study ID #: B1621019
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2013
• Last updated: April 1, 2014
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

• Patients with cardiovascular event within 6-months of screening

• Patients with diabetic complications

• Female subjects who are pregnant or planning to become pregnant

• Subjects with unstable medical conditions (eg, hypertension)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PF-04937319 once-daily
Tablets, 300 mg once-daily with breakfast, 14-days
• PF-04937319 split-dose
tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
• Sitagliptin once-daily
tablets, 100 mg once-daily with breakfast, 14-days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	High Point	North Carolina
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Effects: Area Under Effect Curve (AUE) From 0-X Hour	AUC is a measure of plasma glucose levels over time; used to characterize anti-diabetic effect of drug	Day 1 and Day 14 of each period	No
Secondary	fasting plasma glucose	Effect of drug on fasting plasma glucose	Day 0, 1, 13, 14	No
Secondary	pre-meal insulin	pre-breakfast, pre-lunch, pre-dinner levels of plasma insulin	Day 0 and Day 14	No
Secondary	pre-meal C-peptide	pre-breakfast, pre-lunch, pre-dinner levels of serum C-peptide	Day 0 and Day 14	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 14	No
Secondary	Area Under the Curve From Time Zero to 24hrs	AUC(0-24) = area-under-drug-concentration curve from zero to 24hrs post AM dose	Day 14	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		Day 14	No
Secondary	Minimum Observed Plasma Trough Concentration (Cmin)		Day 14	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Day 14	No
Secondary	Apparent Oral Clearance (CL/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	Day 14	No
Secondary	Apparent Volume of Distribution (Vz/F)	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	Day 14	No

External Links

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