Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
NCT ID: NCT01054300
Last Updated: 2019-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2010-02-17
2010-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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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.
Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Placebo
Placebo to ertugliflozin administered as a single dose
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.
Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Placebo
Placebo to ertugliflozin administered as a single dose
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.
Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
Placebo
Placebo to ertugliflozin administered as a single dose
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.
Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
Placebo
Placebo to ertugliflozin administered as a single dose
Interventions
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Ertugliflozin 2 mg single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg split into twice daily
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Ertugliflozin 4 mg single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 4 mg split into twice daily
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
Placebo
Placebo to ertugliflozin administered as a single dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
Other Identifiers
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B1521007
Identifier Type: OTHER
Identifier Source: secondary_id
MK-8835-040
Identifier Type: OTHER
Identifier Source: secondary_id
8835-040
Identifier Type: -
Identifier Source: org_study_id
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