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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01933672
First received: August 28, 2013
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
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

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: PF-04937319 once-daily Drug: PF-04937319 split-dose Drug: Sitagliptin once-daily Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14 [ 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 ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 [ Time Frame: 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.

  • Change From Baseline in Pre-meal C-Peptide on Day 14 [ Time Frame: 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.

  • Change From Baseline in Pre-meal Insulin on Day 14 [ Time Frame: 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.

  • 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 [ Time Frame: Day 1 up to Day 14 ]
    The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.

  • 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 [ Time Frame: Day 1 up to Day 14 ]
    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).

  • Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern [ Time Frame: Day 1 up to Day 14 ]
    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.

  • Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14 [ 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. ]
    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.

  • Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14 [ 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. ]
    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.

  • Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14 [ 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. ]
    Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.

  • Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14 [ 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. ]
    Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.

  • Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14 [ 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. ]
    Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.

  • Plasma PF-04937319 Time for Cmax (Tmax) on Day 14 [ 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. ]
    Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.


Enrollment: 33
Study Start Date: October 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04937319 once-daily Drug: PF-04937319 once-daily
Tablets, 300 mg once-daily with breakfast, 14-days
Experimental: PF-04937319 split-dose Drug: PF-04937319 split-dose
tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
Active Comparator: Sitagliptin once-daily Drug: Sitagliptin once-daily
tablets, 100 mg once-daily with breakfast, 14-days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933672

Locations
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Miami Research Associates, Inc.
South Miami, Florida, United States, 33143
MRA Clinical Research, LLC
South Miami, Florida, United States, 33143
United States, North Carolina
High Point Clinical Trials Center, LLC
High Point, North Carolina, United States, 27265
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
United States, Texas
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229
United States, Wisconsin
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01933672     History of Changes
Other Study ID Numbers: B1621019
Study First Received: August 28, 2013
Results First Received: June 17, 2016
Last Updated: August 3, 2016

Keywords provided by Pfizer:
Phase 1b
type 2 diabetes
metformin background
PF-04937319

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017