Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00639600
• Date of registration: 14/03/2008
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Grenoble
• Public title: Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft GRAGIL1
• Scientific title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1
• Date of first enrolment: June 2008
• Target sample size: 21
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00639600
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Switzerland

Contacts

• Name: Pierre Y Benhamou, MD, PhD
• Affiliation: University Hospital of Grenoble, Department of Endocrinology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 1 diabetes mellitus

- Disease duration > 5 years

- ketose antecedents

- Basal and stimulated plasma C-< 0.2 ng/ml,<0.06 nmol/l (glycemia must be measured
simultaneously_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à
T0 and T 6 min)

- Established kidney graft = 6 months

- Current creatinine clearance: = 50 ml/min/1.73 m² and Proteinuria < 0.5 g/24h

- HbA1C< 12%

Exclusion Criteria:

- Hemostasis problems

- Documented hepatic pathology

- Patient under 18 or over 65 year-old

- Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and
transplantation day) or BMI > 26

- Men with body weight > 75 kg (tolerance of 3 kg between inclusion day and
transplantation day) or BMI > 26

- insuline needs > 0.7 U/kg/j or 50 U/j

- Serious life-threatening pathology

- untreated hyperlipidemia

- Hypersensitivity to drugs rapamycine-alike

- Liver disease (transaminases or total bilirubin = 3N)

- Failure to communicate or cooperate with the investigator

Exclusion criteria that are specific to the use of Rapamycine

- Hypercholesterolemia (> 350mg/dl, 9,1 mmol/l) not controlled

- Hypertriglyceridemia (> 500 mg/dl, 5,6 mmol/l) not controlled

- Leukocytes > 4500 /mm3 , neutrophils > 2000/ mm3, platelets > 100000/ mm3

- Any clinical or biological pathology that could interfere with the study

- Past or present neoplasia (with the exception of non melanoma skin cancers)

- Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs.
Low-dose aspirin is permitted.

- Pregnancy, lactation, pregnancy project or absence of efficient contraception

- Any medical or psychosocial condition susceptible to interfere with the study, such
as drug abuse or recent alcohol abuse



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Procedure: human pancreatic islet transplantation

Primary Outcome(s)

Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves [Time Frame: 12 months]

Secondary Outcome(s)

Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs [Time Frame: 12 months]

Secondary ID(s)

95/CHUG/10/C2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors