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Type 1 Diabetes MellitusPhase 1/2GRAGIL1NCT00639600

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

A Phase 1/2 study testing human pancreatic islet transplantation in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble at 7 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
human pancreatic islet transplantation
Type of treatment
Surgery or procedure
How many people
21 participants
Where
7 sitesin 2 countries
Study dates
Jun 2008to May 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

France6 sites

  • University Hospital

    Besançon, 25000

  • University Hospital, Department of Endocrinology

    Grenoble, 38043

  • University Hospital, Department of Endocrinology

    Lyon, 69000

  • University Hospital, Department of Endocrinology

    Montpellier, 34000

  • University Hospital, Department of Endocrinology

    Nancy, 54000

  • University Hospital, Department of Endocrinology

    Strasbourg, 66000

Other trials in France

Switzerland1 site

  • University Hospital, Department of Surgery

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

Read the detailed description

The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Being tested
human pancreatic islet transplantation
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human pancreatic islet transplantationProcedure or surgery

    human pancreatic islet transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves

    Measured: 12 months

Secondary outcomes (1)

  1. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Why it stopped: a new study has began recently

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639600
Sponsor's protocol ID
95/CHUG/10/C2
Acronym
GRAGIL1
Status last verified
May 2010
First submitted
14 Mar 2008
Last updated
31 May 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.

    PubMed 26068866

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing human pancreatic islet transplantation in people with Type 1 Diabetes Mellitus, run by University Hospital, Grenoble at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: a new study has began recently). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00639600, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2010.

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