At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Ertugliflozindrug
Likely dose
Ertugliflozin 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Non-Randomized, Open-Label, Single Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating Ertugliflozin for Renal Impairment and Type 2 Diabetes Mellitus. Completed, enrolled 36 participants.
Detailed Summary
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment, Type 2 Diabetes Mellitus
Countries--
CollaboratorsPfizer
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionOct 2014
Study CompletionOct 2014
TodayJul 2026
First PostedSep 24, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 6, 2014
Study CompletionOct 16, 2014
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 12.8 years ago
Interventions
Ertugliflozindrug
Single oral administration of 3 X 5 mg tablets.