Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02175121
First received: June 24, 2014
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.


Condition Intervention Phase
Diabetes Mellitus, Type II
Drug: Placebo
Drug: PF-06291874
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of Pf-06291874 Given As Monotherapy To Adults With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean daily glucose [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    plasma glucose level

  • fasting plasma glucose [ Time Frame: Baseline, Day 14 and the mean of Day 28 and 29 ] [ Designated as safety issue: No ]
    plasma glucose level in fasting state

  • Change from Baseline in Lipid Parameters [ Time Frame: Day 14 and mean of Day 28 and 29 ] [ Designated as safety issue: No ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), non-HDL, oxidized LDL, LDL particle size and number, Lp-a, ApoB100 and Triglyceride blood concentrations.

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    peak or maximum observed concentration

  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: August 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A- Placebo Drug: Placebo
Tablet, once daily for 28 days
Experimental: Treatment B- PF-06291874 Drug: PF-06291874
Tablet, 15 mg, once daily for 28 days
Experimental: Treatment C- PF-06291874 Drug: PF-06291874
Tablet, 35 mg, once daily for 28 days
Experimental: Treatment D- PF-06291874 Drug: PF-06291874
Tablet, 75 mg, once daily for 28 days
Experimental: Treatment E- PF-06291874 Drug: PF-06291874
Tablet, 150 mg, once daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
  • Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
  • HbA1c value at the screening visit meeting once of the following criteria:

    • Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
    • Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
  • Fasting plasma glucose concentrations<270mg/dL at the screening and run-in visit, confirmed by a single repeat, if deemed necessary.
  • Subjects must be willing and able to perform self-tests of blood glucose at least 4 times per day, and maintain a diary for the duration of participation in the study; and therefore, subjects must be literate.

Exclusion Criteria:

  • History of Type 1 diabetes mellitus or secondary forms of diabetes
  • One or more self-reported hypoglycemic episodes of sever intensity within 3 months of screening; or 2 or more self-reported hypoglycemic episodes of severe intensity within the previous 6 months.
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attach within 6 months of screening.
  • History or evidence of diabetic complications with significant end organ damage, such as

    • Proliferative retinopathy and/or macular edema;
    • Diabetic neuropathy complicated by neuropathic ulcers;
  • Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
  • Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  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: NCT02175121

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
Pfizer Investigational Site Not yet recruiting
Anaheim, California, United States, 92801-2811
Pfizer Investigational Site Recruiting
Chula Vista, California, United States, 91911
Pfizer Investigational Site Not yet recruiting
Walnut Creek, California, United States, 94598
United States, Florida
Pfizer Investigational Site Not yet recruiting
DeLand, Florida, United States, 32720
Pfizer Investigational Site Not yet recruiting
Hollywood, Florida, United States, 33024
Pfizer Investigational Site Not yet recruiting
Miami, Florida, United States, 33126
Pfizer Investigational Site Not yet recruiting
Orlando, Florida, United States, 32806
United States, Kentucky
Pfizer Investigational Site Not yet recruiting
Louisville, Kentucky, United States, 40213
United States, New York
Pfizer Investigational Site Not yet recruiting
Buffalo, New York, United States, 14202
United States, Ohio
Pfizer Investigational Site Not yet recruiting
Cincinnati, Ohio, United States, 45255
United States, Texas
Pfizer Investigational Site Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Washington
Pfizer Investigational Site Not yet recruiting
Renton, Washington, United States, 98055
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02175121     History of Changes
Other Study ID Numbers: B4801011
Study First Received: June 24, 2014
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014