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Effects Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01054300
First received: January 20, 2010
Last updated: May 20, 2016
Last verified: May 2016

January 20, 2010
May 20, 2016
February 2010
April 2010   (Final data collection date for primary outcome measure)
  • 24-hour mean urinary glucose excretion [ Time Frame: Up to 24 hours in each dosing period ]
  • Time course of the urinary glucose excretion [ Time Frame: Up to 24 hours in each dosing period ]
  • 24-hour weighted mean plasma glucose. [ Time Frame: Up to 24 hours in each dosing period ]
  • Weighted mean postprandial plasma glucose [ Time Frame: Up to 24 hours in each dosing period ]
  • Fasting plasma glucose [ Time Frame: Up to 24 hours in each dosing period ]
  • Fasting C-peptide [ Time Frame: Up to 24 hours in each dosing period ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 7 in each dosing period ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 1 in each dosing period ]
  • Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin [ Time Frame: Up to 24 hours in each dosing period ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 24 hours in each dosing period ]
  • Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to 24 hours in each dosing period ]
  • Pharmacodynamic Effect - 24hr as well as time course over intervals of 0-4, 4-8, 8-12 and 12-24hr, of urinary glucose excretion (UGE) and 24-hr mean plasma glucose, fasting plasma glucose and C-peptide [ Time Frame: 3-weeks ]
  • Safety and Tolerability - adverse events, serious adverse events, clinical lab tests, vitals, 12-lead electrocardiograms [ Time Frame: 3-weeks ]
  • Pharmacokinetics - Area-under-the-curve from 1st dose to last PK collection in each period (AUClast), maximum plasma concentration (Cmax), and time of Cmax (Tmax) [ Time Frame: 3-weeks ]
  • Pharmacokinetic (PK) - pharmacodynamics (PD) - relationship, if any, between PF-04971729 PK and selected PD endpoints [ Time Frame: 3-weeks ]
Complete list of historical versions of study NCT01054300 on ClinicalTrials.gov Archive Site
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Effects Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
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
This is a Phase 1 pharmacokinetic, pharmacodynamic study to understand the manner in which the body responds to, as well as how the drug is handled by the body, with once vs twice daily dosing of ertugliflozin (PF-04971729, MK-8835) in participants with type 2 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
  • Diabetes Mellitus, Type 2
  • Adult
  • Drug: Ertugliflozin 2 mg single dose
    Ertugliflozin 2 mg dose (using 1 mg strength tablets), administered as a single dose
  • Drug: Ertugliflozin 2 mg split into twice daily
    Ertugliflozin 1 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
  • Drug: Ertugliflozin 4 mg single dose
    Ertugliflozin 4 mg dose (using 1mg strength tablets), administered as a single dose
  • Drug: Ertugliflozin 4 mg split into twice daily
    Ertugliflozin 2 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
  • Drug: Placebo
    Placebo to Ertugliflozin
  • Experimental: Ertugliflozin (E) 2 mg/Placebo (P)→E 1 mg/E 1 mg
    Period 1 (AM/PM) dose: E 2 mg/Placebo. Period 2 (AM/PM) dose: E 1 mg /E 1 mg. 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: E 1 mg/E 1 mg→E 2 mg/P
    Period 1 (AM/PM) dose: E 1 mg/E 1 mg. Period 2 (AM/PM) dose: E 2 mg /Placebo. 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: E 4 mg/P→E 2 mg/E 2 mg
    Period 1 (AM/PM) dose: E 4 mg/Placebo. Period 2 (AM/PM) dose: E 2 mg /E 2 mg. 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: E 2 mg/E 2 mg→E 4 mg/P
    Period 1 (AM/PM) dose: E 2 mg/E 2 mg. Period 2 (AM/PM) dose: E 4 mg /Placebo. 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes, on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion Criteria:

  • Patients with type 1 diabetes, patients with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01054300
8835-040
No
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2016

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