Clinical trial NCT01933672: Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1b
type 2 diabetes
metformin background
PF-04937319
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
timeFrame: Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14
timeFrame: Day 14
measure: Change From Baseline in Pre-meal C-Peptide on Day 14
timeFrame: Day 14
measure: Change From Baseline in Pre-meal Insulin on Day 14
timeFrame: Day 14
measure: Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)
timeFrame: Day 1 up to Day 14
measure: Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group
timeFrame: Day 1 up to Day 14
measure: Change From Baseline in Body Weight (kg)
timeFrame: Day 1 up to Day 14
measure: Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
timeFrame: Day 1 up to Day 14
measure: Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern
timeFrame: Day 1 up to Day 14
measure: Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
measure: Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
measure: Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
measure: Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
measure: Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
measure: Plasma PF-04937319 Time for Cmax (Tmax) on Day 14
timeFrame: Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: South Miami
country: United States
facility: MRA Clinical Research, LLC
state: Florida
city: High Point
country: United States
facility: High Point Clinical Trials Center, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
city: West Bend
country: United States
facility: Spaulding Clinical Research, LLC
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: