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

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ClinicalTrials.gov Identifier: NCT01148680
Recruitment Status : Active, not recruiting
First Posted : June 22, 2010
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

June 21, 2010
June 22, 2010
July 21, 2017
June 2010
August 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01148680 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Trial Comparing Metabolic Efficiency of Islet Graft to Intensive Insulin Therapy for Type 1 Diabetes's Treatment
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
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 Name: human pancreatic islet transplantation
  • 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)

    Intervention: Biological: Islet Graft
  • 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)

    Intervention: Biological: Islet Graft

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
40
December 2017
August 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Switzerland
 
 
NCT01148680
DCIC 08 31
Yes
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Pierre-Yves Benhamou, Pr University Hospital, Grenoble
University Hospital, Grenoble
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP