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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
33
Tablets, 300 mg once-daily with breakfast, 14-days
tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
tablets, 100 mg once-daily with breakfast, 14-days
Avail Clinical Research, LLC
DeLand, Florida, United States
Miami Research Associates, Inc.
South Miami, Florida, United States
MRA Clinical Research, LLC
South Miami, Florida, United States
High Point Clinical Trials Center, LLC
High Point, North Carolina, United States
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.
Time frame: 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
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time "0"), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15.
Time frame: Day 14
Change From Baseline in Pre-meal C-Peptide on Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.
Time frame: Day 14
Change From Baseline in Pre-meal Insulin on Day 14
Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.
Time frame: Day 14
Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)
Time frame: Day 1 up to Day 14
Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.
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Community Research
Cincinnati, Ohio, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Time frame: Day 1 up to Day 14
Change From Baseline in Body Weight (kg)
Time frame: Day 1 up to Day 14
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =\<20 mmHg change from baseline, supine/sitting/standing SBP less than (\<) 90 mm Hg; sitting diastolic BP (DBP) \>=20 mm Hg change from baseline, sitting SBP =\<20 mmHg change from baseline, supine/sitting/standing DBP \<50 mm Hg; 2), pulse rate (supine): \<40 or greater than (\>) 120 beats per minute (bpm).
Time frame: Day 1 up to Day 14
Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern
ECG criteria of potential clinical concern were 1), PR interval: \>=300 milliseconds (msec); \>=25% increase when baseline \>200 msec; or increase \>=50% when baseline \<=200 msec; 2), QRS interval: \>=140 msec; \>=50% increase from baseline; 3), QTc interval using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>500 msec; absolute change 30 - \<60, \>=60 msec.
Time frame: Day 1 up to Day 14
Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14
The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.
Time frame: 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.
Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14
The PK parameters were summarized descriptively by treatment as appropriate. 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 PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 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.
Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14
Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.
Time frame: 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.
Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14
Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.
Time frame: 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.
Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14
Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.
Time frame: 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.
Plasma PF-04937319 Time for Cmax (Tmax) on Day 14
Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.
Time frame: 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.