At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
BI 10773drug
Likely dose
Not stated in 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.
An Open-label 8-week Adjunctive-to-insulin and Renal Mechanistic Pilot Trial of BI 10773 in Type 1 Diabetes Mellitus (the ATIRMA Trial)
In Brief
A Phase 2 clinical trial evaluating BI 10773 for Diabetes Mellitus, Type 1. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJul 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedJul 12, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.0 years ago
Interventions
BI 10773drug
Oral once daily