NCT01974674|UnknownPhase 2DMC
Allogeneic Islet Transplantation for the Treatment of Type 1 Diabetes
GRIIF
Loading search results
Sponsor study identifier
interventional
19
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
It is a multicentre, sequential, phase II clinical trial, aiming at evaluating the allogeneic islet transplantation for the treatment of type 1 diabetes. 19 patients with type 1 diabetes will be included and ideally distributed evenly: patients with unstable diabetes without renal insufficiency (AI group for "islet alone" by the international customary determination) and patients with a functioning kidney transplant (IAK group for "islet after kidney"). The main endpoint will be defined by the restoration of normal glycemic control without insulin at 6 months after graft.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 28, 2013
Actual (reported)November 1, 2013
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
restoration of normal glycemic control without insulin
the restoration of normal glycemic control without insulin therapy will be evaluated by measuring \- A fasting glucose (\> 8 hours) less than 1.25 g/L and a 2 hours glucose after oral intake of 75g of glucose, less than 2 g/L in a patient without insulin for at least 15 consecutive days during the the first 6 months from day 0.
6 months after graft
Restoration of normal glycemic control without insulin for a year
1 year
Obtaining an improvement in glycemic control
within 2 years after inclusion
Obtaining a remission of diabetes
within 2 years after inclusion
Improved metabolic profile determined by the OGTT and hyperglycemic clamp
within 2 years after inclusion
Decreased glycemic variability
within 2 years after inclusion
Allogeneic transplantation of intrahepatic islet number required for insulin independence of obtaining, with a threshold dose of 9,000 IEQ/kg body weight of the recipient and a maximum sequence number of 3 infusions. The patient will receive after transplantation immunosuppressive therapy with Thymoglobulin for induction, Prograf and Cellcept, both of which are given throughout the duration of the study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Saint Louis hospital
Paris, Île-de-France Region, 75010, France
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 29, 2016
Record last verified: 2016-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: