Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

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NCT01054300

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Adult
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Participants with type 1 diabetes mellitus, participants with stroke, unstable angina,
heart attack in last 6-months, uncontrolled blood pressure.

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Type 2 Diabetes Mellitus, AdultEffects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
NCT01054300
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus
Brief Summary This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in adults with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Adult
Intervention  ICMJE
  • Drug: Ertugliflozin 2 mg single dose
    Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
  • Drug: Ertugliflozin 2 mg split into twice daily
    Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
  • Drug: Ertugliflozin 4 mg single dose
    Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
  • Drug: Ertugliflozin 4 mg split into twice daily
    Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
  • Drug: Placebo
    Placebo to ertugliflozin administered as a single dose
Study Arms  ICMJE
  • Experimental: Cohort 1: Ertu 2 mg/Placebo (Pbo)?Ertu 1 mg/Ertu 1 mg
    Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
    Interventions:
    • Drug: Ertugliflozin 2 mg single dose
    • Drug: Ertugliflozin 2 mg split into twice daily
    • Drug: Placebo
  • Experimental: Cohort 1: Ertu 1 mg/Ertu 1 mg?Ertu 2 mg/Pbo
    Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
    Interventions:
    • Drug: Ertugliflozin 2 mg single dose
    • Drug: Ertugliflozin 2 mg split into twice daily
    • Drug: Placebo
  • Experimental: Cohort 2: Ertu 4 mg/Pbo?Ertu 2 mg/Ertu 2 mg
    Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
    Interventions:
    • Drug: Ertugliflozin 4 mg single dose
    • Drug: Ertugliflozin 4 mg split into twice daily
    • Drug: Placebo
  • Experimental: Cohort 2: Ertu 2 mg/Ertu 2 mg?Ertu 4 mg/Pbo
    Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a >= 7 day washout period between Period 1 and Period 2.
    Interventions:
    • Drug: Ertugliflozin 4 mg single dose
    • Drug: Ertugliflozin 4 mg split into twice daily
    • Drug: Placebo
Publications * Dawra VK, Liang Y, Shi H, Bass A, Hickman A, Terra SG, Zhou S, Cutler D, Sahasrabudhe V. A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects . Int J Clin Pharmacol Ther. 2019 Apr;57(4):207-216. doi: 10.5414/CP203343.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2010)		52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 7, 2010
Actual Primary Completion Date April 7, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria:

  • Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01054300
Other Study ID Numbers  ICMJE 8835-040
B1521007 ( Other Identifier: Pfizer Protocol Number )
MK-8835-040 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialD…
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP