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Type 1 Diabetes MellitusPhase 1/2NCT00437398

Islet Transplantation for Type 1 Diabetes Mellitus

A Phase 1/2 study testing Islet Transplant in people with Type 1 Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.

Terminated

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

Official record
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Trial summary

The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe hypoglycemia and implemented by less than 50 % of the population of such patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Islet Transplant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jul 2006to Jan 2012
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Duration of diabetes: 5 years or more
  • Type 1 diabetes with C-peptide < 200 pmol/L and a simultaneous plasma glucose between 60 and 250 mg/dl
  • Complex insulin program supervised by an endocrinologist for at least 6 months
  • Hypoglycemic unawareness diagnosed using Clarke Awareness Questionnaire
  • Body weight < 70 kg
  • Body Mass Index < 30 kg/m^2
Show all 15Show fewer
  • Insulin requirement < 40 units/day by multiple daily injections or < 30 units /day by external insulin pump or < 0.6 unit/kg/day with a HbA1c < 7.0 % ( Normal < 6 %)
  • No overt cardiovascular disease
  • No laser treatment for retinopathy
  • Retinopathy diagnosed by ophthalmologist to be stable and requiring no further evaluation for at least one year
  • Women of child bearing age will have a negative pregnancy test at screening and time of trial initiation
  • Women enrolled in the trial should be willing to practice birth control while on immunosuppression
  • No psychologic issues that would interfere with adherence to safe clinical practice
  • Blood type (ABO) compatibility
  • No evidence of chronic liver disease (aspartate aminotransferase (AST) < 2.5 times normal, alanine aminotransferase (ALT) < 2.5 times normal, international normalized ratio (INR) < 1.4, No evidence of fatty liver on abdominal ultrasound.

Who cannot join

  • Ongoing infection
  • Ongoing alcohol or drug abuse
  • Clinical portal hypertension
  • Gall stones
  • Liver hemangioma on ultrasound interfering with islet infusion
  • Lack of updated immunization
Show all 26Show fewer
  • Unstable cardiovascular status as defined by:
  • Myocardial infarction/acute coronary syndrome in last year
  • Significant coronary atherosclerosis on angiography
  • Active ischemia at evaluation
  • Pre-trial low-density lipoprotein (LDL) cholesterol > 100 and triglycerides > 200 mg/dl with or without lipid lowering therapy
  • Active peptic ulcer disease
  • Previous organ transplantation except islet transplantation
  • Negative serology for Epstein-Barr Virus (EBV) or ongoing acute EBV infection
  • Previous malignancy unless
  • 5 years ago
  • basal cell cancer
  • squamous cell cancer
  • Requiring steroid therapy for any reason
  • Positive Purified Protein Derivative (PPD - Tuberculosis Skin Test)
  • Serological evidence of HIV, Hepatitis C or Hepatitis B
  • Chronic anemia
  • Single Antigen B (SAB) normalized value >1500
  • Renal disease
  • Iothalamate clearance < 70 cc/min
  • 24 hour urine protein > 500 mg/24 hours

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe hypoglycemia and implemented by less than 50 % of the population of such patients. Outcomes of transplantation of isolated human islets have substantially improved and been performed at about 40 institutions around the world. We are proposing a clinical phase 1/phase 2 study of islet transplantation alone evaluating safety and efficacy in five patients with type 1 diabetes. Islet isolation from deceased donor pancreases will be performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional Radiology into the portal venous system. Following islet infusion, patients will be hospitalized for 48 hours in the General Clinical Research Center (GCRC) or at the Rochester Methodist Hospital. Multiple safety and efficacy outcomes will be followed on multiple occasions during the first year and periodically thereafter.

Being tested
Islet Transplant
Keywords
hypoglycemic unawareness
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.

  • Islet TransplantBiological

    Purified pancreatic islets

Study groups in NCT00437398
Study groupRoleWhat they receive
Islet TransplantExperimentalSubjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
Receives: Biological: Islet Transplant

What is being measured

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

  1. Mean Number of Hypoglycemic Events After Transplant

    Hypoglycemia is an abnormally diminished content of glucose in the blood.

    Measured: 3, 6, 9, and 12 months since islet transplantation

Secondary outcomes (1)

  1. Mean Glycated Hemoglobin (HbA1c) Since Transplant

    HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.

    Measured: 3, 6, 9, and 12 months since islet transplantation

Timeline

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

  1. First posted21 Feb 2007 (estimated)
  2. Study startJul 2006
  3. Primary completionJan 2012
  4. Study completionJan 2012

Why it stopped: The study was terminated early due to difficulty in recruiting subjects, and ran short of funds.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00437398
Sponsor's protocol ID
06-003564
Other IDs
UL1RR024150
Status last verified
Mar 2013
First submitted
20 Feb 2007
Last updated
25 Apr 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Islet Transplant in people with Type 1 Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.

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 15 inclusion and 26 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 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Number of Hypoglycemic Events After Transplant (time frame: 3, 6, 9, and 12 months since islet transplantation). 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 NCT00437398.

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 25 Apr 2013.

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