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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
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Adult Drug: Ertugliflozin 2 mg single dose Drug: Ertugliflozin 2 mg split into twice daily Drug: Ertugliflozin 4 mg single dose Drug: Ertugliflozin 4 mg split into twice daily Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Placebo
Placebo to Ertugliflozin
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.
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: Placebo
Placebo to Ertugliflozin
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.
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: 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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01054300

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01054300     History of Changes
Other Study ID Numbers: 8835-040
Study First Received: January 20, 2010
Last Updated: May 20, 2016

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

ClinicalTrials.gov processed this record on August 23, 2017