At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
Islet Graftbiological
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.
Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes
In Brief
A Phase 3 clinical trial evaluating Islet Graft for Diabetes Mellitus, Type 1. Completed, enrolled 50 participants across 9 sites in 2 countries.
Detailed Summary
Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesFrance, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionAug 2018
Study CompletionSep 2018
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartJun 1, 2010
Primary CompletionAug 1, 2018
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 16.0 years ago
Interventions
Islet Graftbiological
Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)