Trial Comparing Metabolic Efficiency of Islet Graft to Intensive Insulin Therapy for Type 1 Diabetes's Treatment (TRIMECO)

January 24, 2020 updated by: University Hospital, Grenoble

Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable type 1 diabetes versus patients with unstable type 1 diabetes and who underwent kidney transplantation.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Strasbourg, Alsace, France, 67000
        • University Hospital, Department of Endocrinology
    • Auvergne
      • Clermont Ferrand, Auvergne, France, 63003
        • University Hospital Gabriel Montpied, Department of Endocrinology
    • Franche-Comté
      • Besançon, Franche-Comté, France, 25000
        • University Hospital Besançon, Department of Endocrinology
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34000
        • University Hospital, Department of Endocrinology
    • Lorraine
      • Nancy, Lorraine, France, 54000
        • University Hospital, Department of Endocrinology
    • Nord Pas De Calais
      • Lille, Nord Pas De Calais, France, 59000
        • University Hospital, Department of General Surgery and Endocrinology
    • Rhône-Alpes
      • Grenoble, Rhône-Alpes, France, 38000
        • University Hospital, Department of Endocrinology
      • Lyon, Rhône-Alpes, France, 69000
        • HCL Sud, Department of Endocrinology
  • Switzerland
      • Geneve, Switzerland, CH-1211
        • Hopitaux Universitaires de Genève, Department of Visceral Surgery and Transplant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with type 1 diabetes or C-peptide negative diabetes Diabetes duration > 5 years
  • No residual insulin secretion (plasmatic basal and stimulated C-peptide < 0.3 ng/ml)
  • HbA1c considered acceptable by the selection committee
  • Insulin needs < 0.85 IU/kg/day

  • Islet cell infusion after kidney graft

    • Patient with terminal renal failure and functional kidney graft for at least 6 months (creatinine clearance greater than or equal to 35 ml/min)
    • Patient whose glycaemic control obtained with insulin therapy could threaten kidney graft survival and/or significantly alter quality of life. This situation is assessed by a diabetologist

  • Islet cell infusion only: patient with major glycaemic variability despite proper intensive insulin therapy, closely monitored by a diabetologist. Poor glucose control, assessed by a diabetologist, endangers the patient's life and/or significantly alters personal, social, professional and family quality of life. At least one of these criteria must be fulfilled :

    • Hypoglycaemia unawareness, blood glucose level < 3mmol/L or 0.54 mg/L
    • At least 2 severe hypoglycaemia events (defined by the necessity of a third party's assistance) per year or a ketoacidosis requiring patient's hospitalization during the last year.
    • Impairment of quality of life or life-threat for patient or other persons, or progressive complications despite optimal insulin therapy
  • Social Security membership or benefit from Social Welfare

Exclusion Criteria:

  • Age< 18 and > 65
  • Diabetes duration < 5 years
  • Criteria specifically related to the islet intraportal injection procedure: hemostasis problem, haemoglobin level < 11g/dL for women and <12g/dL for men, abnormalities of complete blood count, documented liver pathology (alkaline phosphatases, gamma GT, transaminases levels over twice normal values) ; pancreatitis history, gallbladder stones that could potentially migrate; HLA hyperimmunisation (PRA >20%).

  • Criteria related to diabetes complications :

    • Non-stabilized proliferating diabetic retinopathy
    • Creatininaemia > 16 mg/dL
  • Exclusion criteria non-specifically related to islet infusion: evolutive vascular disease, evolutive cardiopathy (especially myocardial infarction less than 6 months ago, cerebrovascular stroke less than 6 months ago, evolutive arteritis with trophic disorders) ; systemic infection including hepatitis C and HIV ; leuconeutropenia ; thrombocytopenia, non-stabilized neoplastic pathology ; pregnancy or project of pregnancy within the next 24 months ; poor therapeutic compliance
  • Criteria related to immunosuppressive protocol : renal failure (glomerular filtration < 35 ml/min/1.73 m²) and/or proteinuria > 0.5 g/24h ; non-treated hyperlipidemia (LDL-C > 130 mg/dL) ; blood pressure > 160/100 mmHg
  • Clinical insulin resistance : assessed by patient's weight, BMI and exogenous insulin requirements (BMI > 30 kg/m² or insulin dose > 0.85 UI/kg/day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate registration on islet graft list

group 1 'immediate registration on infusion waiting list' : patients who will be immediately registrated on islet cell infusion waiting list after randomization.

Intervention : Procedure/surgery (islet graft)
Biological: Islet Graft
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)
Other Names:
  • human pancreatic islet transplantation
Active Comparator: delayed registration on islet graft list

group 2 'delayed registration on infusion waiting list' : patients who will be registrated 6 months later on islet cell infusion waiting list after randomization.

Intervention : Procedure/surgery (islet graft)
Biological: Islet Graft
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)
Other Names:
  • human pancreatic islet transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ß score evaluation 6 months after first infusion (group 1 'immediate registration on infusion waiting list') or 6 months after inclusion (group 2: 'delayed registration on infusion waiting list')
Time Frame: 6 months after first infusion (group 1) or 6 months after inclusion (group 2)
Metabolism evaluated by ß score. This score uses 4 intermediate scores ranging from 0 to 2 associated with the following 4 indicators: HbA1c, basal C peptide (or stimulated C-peptide), daily insulin dose (U/kg) or intake of oral antidiabetic drugs and fasting glycaemia. The total of the intermediate scores ranges from 0 to 8. Islet graft will be considered as successful if the ß score is equal to or greater than 6
6 months after first infusion (group 1) or 6 months after inclusion (group 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of metabolism indicators : ß-score and individual analysis of the 4 components of the ß-score
Time Frame: 6 and 12 months
Metabolism indicators at 6 and 12 months : ß-score (quantitative analysis by mean score comparison), individual analysis of the 4 components of the ß-score (HbA1c, basal C peptide (or stimulated C-peptide), daily insulin dose (U/kg) or intake of oral antidiabetic drugs and fasting glycaemia), lability index, ADRR score, Clarke score
6 and 12 months
Measure of quality of life (SF36, DQOL, DHP)
Time Frame: at inclusion time, at 6 months and at 12 months after first infusion (group 1) or after inclusion (group 2)
Measure of quality of life (SF36, DQOL, DHP) for Group 1 ('immediate registration on infusion waiting list'): at inclusion time, at 6 months and at 12 months after first infusion For Group 2 ('delayed registration on infusion waiting list'): at inclusion time, 6 months after inclusion, at 6 months and at 12 months after first infusion
at inclusion time, at 6 months and at 12 months after first infusion (group 1) or after inclusion (group 2)
Cost evaluation of islet cell infusion
Time Frame: 6 months
Cost comparison between islet cell infusion (group 1 'immediate registration on infusion waiting list')and intensive insulin therapy (group 2 'delayed registration on infusion waiting list') at 6 months, from a hospital perspective as well as a health-insurance system perspective
6 months
Evaluation of side effects and iatrogenic effects
Time Frame: at 6 months and 12 months after infusion
Evaluation of side effects and iatrogenic effects at 6 months and 12 months after infusion
at 6 months and 12 months after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pierre-Yves Benhamou, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 08 31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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