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: June 4, 2015
Last verified: June 2015
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Time course of the urinary glucose excretion [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • 24-hour weighted mean plasma glucose. [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • Weighted mean postprandial plasma glucose [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • Fasting C-peptide [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 7 in each dosing period ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 1 in each dosing period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]
  • Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to 24 hours in each dosing period ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

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: June 4, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 30, 2015