Diabetes Mellitus Type 1Phase 2NCT00006505
Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression
A Phase 2 study testing Islet Transplantation in people with Diabetes Mellitus Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy. Islets are cell clusters in the pancreas that contain insulin-producing cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Islet Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2000to 21 Apr 2020
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T1DM for at least 5 years will be eligible for the study provided they exhibit one of the following:
- Hypoglycemia unawareness, as defined by inability to sense hypoglycemia until the blood glucose falls to less than 54 mg/dl or greater than one hypoglycemia reaction in the preceding 20 months and that required outside help and was not explained by a clear precipitant;
- Metabolic instability, as defined by: a) recurrent hypoglycemic or ketoacidotic events requiring more than two hospitalization within the preceding 12 months, b) disruption in quality of life or direct potential danger to the patient or others around them, with more than two hospital admissions or more than four weeks off school or work, or where the individual is no longer able to provide essential care for others; or
- Evidence of early but progressive secondary diabetic complications but which have not progressed to end-stage renal failure
- Failure of intensive insulin management, as judged by an endocrinologist independent of study investigators
Who cannot join
- Significant cardiac disease as defined by: a) a history of a myocardial infarction with the past 6 months or b) coronary angiographic evidence of non-correctable arteriopathy, or c) evidence of ischemia on a functional cardiac examination
- Active alcoholism or other substance abuse (including cigarette smoking) within the past 6 months
- Failure to clear a psychological or psychiatric screen (as assessed by psychological or psychiatric consultation)
- A history of non-adherence. If adherence has been questionable, then an adherence agreement must be entered and compliance demonstrated for at least 3 months
- Active infection including hepatitis B or C, HIV positivity, a positive Mantoux test (unless previously immunized with BCG), or any X-ray evidence of pulmonary infection
- History of malignancy except squamous and basal cell skin cancer, unless disease free for at least 5 years, and cleared by an independent oncological consultation
Show all 23Show fewer
- Obesity (defined by a body mass index of greater than 28) or total body weight greater than 75 kilograms
- C-peptide values greater than or equal to 0.3 pm/ml following a 5.0 gram intravenous arginine infusion
- Inability to provide informed consent
- Age less than 18 or older than age 65
- Creatinine clearance of less than 60 ml/min/m2, or macroalbuminuria of greater than 300 mg/24h
- Baseline Hb of less than 12 g/dl in women, or less than 13 g/dl in men
- WBC count of less than 3,000/mm(3) or a platelet count of less than 100,000/mm(3)
- Baseline LFTs outside of normal range
- Presence of gallstones, liver hemangioma, or evidence of portal hypertension on baseline U/S
- Untreated proliferative retinopathy
- Female patients must not have a positive pregnancy test and must not have the intent for future pregnancy. Any female subject of reproductive age must be able and willing to use an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable)
- Female subjects must not be breastfeeding
- Previous transplant, or evidence of known previous or current anti-HLA antibody
- Insulin requirement of greater than 0.7 iU/kg/day
- HbA1C of greater than 12%
- Inability to reach the hospital for transplantation within 6 hrs of notification. (Ability to reach NIH within the allotted time frame will be determined by the PI for out of town patients)
- Untreated hyperlipidemia
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy. Islets are cell clusters in the pancreas that contain insulin-producing cells. The new procedure features three important advances, first developed by a group in Edmonton, Canada, over the way islet transplants have traditionally been performed: 1) the islets are transplanted immediately after they are removed from the donor; 2) islets are transplanted from two different donors in order to obtain the number of islets in a normal pancreas; and 3) the anti-rejection drug regimen is designed to reduce the harmful side effects of "conditioning" chemotherapy. (In the standard transplant procedure, patients receive intensive chemotherapy following the transplant. This study will use no radiation and lower-dose chemotherapy.)
Patients between the ages of 18 and 65 with the diagnosis of type 1 diabetes mellitus for at least 5 years may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, chest X-ray and tuberculin skin test, electrocardiogram and exercise test for heart function, abdominal ultrasound, psychological evaluation, and an arginine stimulated c-peptide test. The latter test determines if the patient is producing any insulin. Eligibility is restricted to patients who make no insulin at all.
Read more
The study has an active phase lasting 15 months and follow-up that continues indefinitely. Patients will receive 10,000 "islet equivalents" per kilogram (2.2 pounds) of body weight. This will likely require two separate transplant procedures from two donors. Before the first surgery, patients will be given anti-rejection (immune suppressing) drugs, including FK506 and rapamycin (orally) and daclizumab (intravenously). The islets will be infused through a tube placed in the portal vein (the large vein that feeds the liver). After surgery, patients will receive insulin intravenously for 24 hours. They will then have an abdominal ultrasound and blood tests to determine liver function. If fewer than 10,000 islets were transplanted, patients will continue insulin treatment, with the dosages adjusted to account for the transplanted islets. They will take Daclizumab every 2 weeks, and FK506 and rapamycin daily. Blood tests to follow how much of these drugs are in the blood stream will be performed daily at first and then weekly after blood levels of these drugs stabilize. They will be given antibiotics to prevent infections. The arginine test will be repeated 2 weeks after the transplant and periodically thereafter. Blood will be drawn weekly to check drug levels, and monthly for other tests. The investigators will track daily insulin requirements, and these will be recorded monthly.
Patients who require a second transplant to achieve the required amount of islets will return for the procedure when a compatible organ is donated. The second procedure will be done as described above. As before, insulin will be infused for 24 hours following surgery. It will then be stopped, however, and will not be resumed unless blood glucose levels reach above 180 milligrams/deciliter. Patients will continue taking FK506 and rapamycin indefinitely. Daclizumab will be given every 2 weeks for 4 doses following the second transplant, and then stopped. Patients will take an antiviral called ganciclovir for 14 weeks and another antibiotic for 1 year following surgery. For the first year after surgery, patients will have frequent blood tests to monitor drug levels and immune function. They will return to NIH for a complete history and physical examination 2 and 3 years after the final islet transplant and will be contacted yearly by phone to ascertain their general health status and whether they remain insulin independent.
Read the detailed description
We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be
transplanted into the portal vein of patients with type 1 diabetes mellitus (T1DM) in such a way so as to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient s portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and a novel immunosuppressive protocol that avoids glucocorticoids. Up to 20 patients between the ages of 18 and 65 who have been diagnosed with T1DM for at least five years and who have no detectable endogenous insulin producing capacity will be enrolled. Since the study calls for at least 10,000 islet equivalents (IEQs) per kilogram recipient body weight to be transplanted, and since a typical human pancreas yields approximately 2.0 to 4.0 times 105 IEQs, most protocol enrollees will require islets isolated from two different donors. Islets will be transplanted shortly after isolation, and since human donor pancreata are available at unpredictable times, the timing of the islet transplant procedure will also be unpredictable. The study s primary end-point will be insulin independence at one year following the transplantation of at least 10,000 IEQs per kilogram recipient body weight. Secondary endpoints will be evidence of partial islet function as reflected by stimulated c-peptide secretion, a Hgb A1c of 7.0% or less, and the absence of severe hypoglycemia. Additional secondary endpoints will be to determine: 1) if any immune parameters are predictive of islet loss, 2) if islet transplantation has any effect on renal function and 3) if the protocol influences fasting lipid profiles.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Islet Transplantation
- Keywords
- Islet Isolation, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Islet TransplantationDrug
Islet cell transplantation. This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy
| Study group | Role | What they receive |
|---|---|---|
| Transplant | Experimental | Islet cell transplantation Receives: Drug: Islet Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin independence
To reproduce and improve upon a pilot series of clinical islet transplants from Edmonton, using steroid free immunosuppression in conjunction with defined isolation, characterization and transplantation protocols. The study will determine the number of patients receiving an islet allotransplant who are insulin independent at 1 year post-transplant of at least 10,000 IEQ/kg body weight.
Measured: every three months
Secondary outcomes (4)
Islet cell survival
Estimating islet cell survival post transplantation by evaluating the following criteria: Arginine stimulated C- peptide response, Insulin dose expressed as units/kilogram recipient body weight, Incidence of severe hypoglycemia, Monthly monitoring of hemoglobin A1c concentrations for 12 months post transplant completion, and annually for two years thereafter.
Measured: every 3 months
Immune mediated beta cell destruction
These studies will include:A. Autoimmune markers (ICA512, anti-GAD, and anti- insulin)B. Autoantibody isotypesC. Lymphocytotoxic antibody screen (pre-transplant, between the two islet infusions, and 3, 6 and 12 months post last transplant)D. Retrospective lymphocytotoxic crossmatchE. Other- cells and serum will be frozen pre and 3, 6, and 12 months post transplant for assays being developed
Measured: every 3 months
Glomerular filtration rate
To determine whether the islet transplant procedure has had any effect on renal function. Glomerular filtration rate will be assessed as part of the screening procedure, and at 6 months, 1 year, and 3 years following he initial islet transplant
Measured: every 3 months
change in lipid profiles
To determine whether the immunosuppressive regimen influences lipid profiles, a fasting lipid panel will be drawn monthly for 12 months post transplant, and antihyperlipidemic therapy will be monitored.
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2000 (estimated)
- Study start16 Nov 2000
- Primary completion30 Jun 2002
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ranganath Muniyappa, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006505
- Sponsor's protocol ID
- 010036
- Other IDs
- 01-DK-0036
- Status last verified
- Apr 2021
- First submitted
- 17 Nov 2000
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kemp CB, Knight MJ, Scharp DW, Lacy PE, Ballinger WF. Transplantation of isolated pancreatic islets into the portal vein of diabetic rats. Nature. 1973 Aug 17;244(5416):447. doi: 10.1038/244447a0. No abstract available.
PubMed 4200461Ballinger WF, Lacy PE. Transplantation of intact pancreatic islets in rats. Surgery. 1972 Aug;72(2):175-86. No abstract available.
PubMed 4262169Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Perl S, Kushner JA, Buchholz BA, Meeker AK, Stein GM, Hsieh M, Kirby M, Pechhold S, Liu EH, Harlan DM, Tisdale JF. Significant human beta-cell turnover is limited to the first three decades of life as determined by in vivo thymidine analog incorporation and radiocarbon dating. J Clin Endocrinol Metab. 2010 Oct;95(10):E234-9. doi: 10.1210/jc.2010-0932. Epub 2010 Jul 21.
PubMed 20660050Liu EH, Digon BJ 3rd, Hirshberg B, Chang R, Wood BJ, Neeman Z, Kam A, Wesley RA, Polly SM, Hofmann RM, Rother KI, Harlan DM. Pancreatic beta cell function persists in many patients with chronic type 1 diabetes, but is not dramatically improved by prolonged immunosuppression and euglycaemia from a beta cell allograft. Diabetologia. 2009 Jul;52(7):1369-80. doi: 10.1007/s00125-009-1342-7. Epub 2009 May 6.
PubMed 19418039
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression
- ClinicalTrials.gov ID
- NCT00006505
- Acronym / sponsor ID
- 010036
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Islet Isolation, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 16 Nov 2000 (actual)
- Primary completion
- 30 Jun 2002 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 20 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy. Islets are cell clusters in the pancreas that contain insulin-producing cells. The new procedure features three important advances, first developed by a group in Edmonton, Canada, over the way islet transplants have traditionally been performed: 1) the islets are transplanted immediately after they are removed from the donor; 2) islets are transplanted from two different donors in order to obtain the number of islets in a normal pancreas; and 3) the anti-rejection drug regimen is designed to reduce the harmful side effects of "conditioning" chemotherapy. (In the standard transplant procedure, patients receive intensive chemotherapy following the transplant. This study will use no radiation and lower-dose chemotherapy.)
Patients between the ages of 18 and 65 with the diagnosis of type 1 diabetes mellitus for at least 5 years may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, chest X-ray and tuberculin skin test, electrocardiogram and exercise test for heart function, abdominal ultrasound, psychological evaluation, and an arginine stimulated c-peptide test. The latter test determines if the patient is producing any insulin. Eligibility is restricted to patients who make no insulin at all.
The study has an active phase lasting 15 months and follow-up that continues indefinitely. Patients will receive 10,000 "islet equivalents" per kilogram (2.2 pounds) of body weight. This will likely require two separate transplant procedures from two donors. Before the first surgery, patients will be given anti-rejection (immune suppressing) drugs, including FK506 and rapamycin (orally) and daclizumab (intravenously). The islets will be infused through a tube placed in the portal vein (the large vein that feeds the liver). After surgery, patients will receive insulin intravenously for 24 hours. They will then have an abdominal ultrasound and blood tests to determine liver function. If fewer than 10,000 islets were transplanted, patients will continue insulin treatment, with the dosages adjusted to account for the transplanted islets. They will take Daclizumab every 2 weeks, and FK506 and rapamycin daily. Blood tests to follow how much of these drugs are in the blood stream will be performed daily at first and then weekly after blood levels of these drugs stabilize. They will be given antibiotics to prevent infections. The arginine test will be repeated 2 weeks after the transplant and periodically thereafter. Blood will be drawn weekly to check drug levels, and monthly for other tests. The investigators will track daily insulin requirements, and these will be recorded monthly.
Patients who require a second transplant to achieve the required amount of islets will return for the procedure when a compatible organ is donated. The second procedure will be done as described above. As before, insulin will be infused for 24 hours following surgery. It will then be stopped, however, and will not be resumed unless blood glucose levels reach above 180 milligrams/deciliter. Patients will continue taking FK506 and rapamycin indefinitely. Daclizumab will be given every 2 weeks for 4 doses following the second transplant, and then stopped. Patients will take an antiviral called ganciclovir for 14 weeks and another antibiotic for 1 year following surgery. For the first year after surgery, patients will have frequent blood tests to monitor drug levels and immune function. They will return to NIH for a complete history and physical examination 2 and 3 years after the final islet transplant and will be contacted yearly by phone to ascertain their general health status and whether they remain insulin independent.
Detailed description
We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be
transplanted into the portal vein of patients with type 1 diabetes mellitus (T1DM) in such a way so as to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient s portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and a novel immunosuppressive protocol that avoids glucocorticoids. Up to 20 patients between the ages of 18 and 65 who have been diagnosed with T1DM for at least five years and who have no detectable endogenous insulin producing capacity will be enrolled. Since the study calls for at least 10,000 islet equivalents (IEQs) per kilogram recipient body weight to be transplanted, and since a typical human pancreas yields approximately 2.0 to 4.0 times 105 IEQs, most protocol enrollees will require islets isolated from two different donors. Islets will be transplanted shortly after isolation, and since human donor pancreata are available at unpredictable times, the timing of the islet transplant procedure will also be unpredictable. The study s primary end-point will be insulin independence at one year following the transplantation of at least 10,000 IEQs per kilogram recipient body weight. Secondary endpoints will be evidence of partial islet function as reflected by stimulated c-peptide secretion, a Hgb A1c of 7.0% or less, and the absence of severe hypoglycemia. Additional secondary endpoints will be to determine: 1) if any immune parameters are predictive of islet loss, 2) if islet transplantation has any effect on renal function and 3) if the protocol influences fasting lipid profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant | Experimental | Drug: Islet TransplantationIslet cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with T1DM for at least 5 years will be eligible for the study provided they exhibit one of the following:
- Hypoglycemia unawareness, as defined by inability to sense hypoglycemia until the blood glucose falls to less than 54 mg/dl or greater than one hypoglycemia reaction in the preceding 20 months and that required outside help and was not explained by a clear precipitant;
- Metabolic instability, as defined by: a) recurrent hypoglycemic or ketoacidotic events requiring more than two hospitalization within the preceding 12 months, b) disruption in quality of life or direct potential danger to the patient or others around them, with more than two hospital admissions or more than four weeks off school or work, or where the individual is no longer able to provide essential care for others; or
- Evidence of early but progressive secondary diabetic complications but which have not progressed to end-stage renal failure
- Failure of intensive insulin management, as judged by an endocrinologist independent of study investigators
Key exclusion criteria (23 listed)
- Significant cardiac disease as defined by: a) a history of a myocardial infarction with the past 6 months or b) coronary angiographic evidence of non-correctable arteriopathy, or c) evidence of ischemia on a functional cardiac examination
- Active alcoholism or other substance abuse (including cigarette smoking) within the past 6 months
- Failure to clear a psychological or psychiatric screen (as assessed by psychological or psychiatric consultation)
- A history of non-adherence. If adherence has been questionable, then an adherence agreement must be entered and compliance demonstrated for at least 3 months
- Active infection including hepatitis B or C, HIV positivity, a positive Mantoux test (unless previously immunized with BCG), or any X-ray evidence of pulmonary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Islet TransplantationIslet cell transplantation. This study will test whether a new islet transplant procedure will enable patients with type 1 diabetes mellitus to stop insulin therapy | Drug | Transplant |
Primary outcome
Insulin independence
Time frame: every three months
To reproduce and improve upon a pilot series of clinical islet transplants from Edmonton, using steroid free immunosuppression in conjunction with defined isolation, characterization and transplantation protocols. The study will determine the number of patients receiving an islet allotransplant who are insulin independent at 1 year post-transplant of at least 10,000 IEQ/kg body weight.
4 secondary outcomes
Islet cell survival
Time frame: every 3 months
Immune mediated beta cell destruction
Time frame: every 3 months
Glomerular filtration rate
Time frame: every 3 months
change in lipid profiles
Time frame: every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Background: PubMed 4200461Kemp CB, Knight MJ, Scharp DW, Lacy PE, Ballinger WF. Transplantation of isolated pancreatic islets into the portal vein of diabetic rats. Nature. 1973 Aug 17;244(5416):447. doi: 10.1038/244447a0. No abstract available.
- Background: PubMed 4262169Ballinger WF, Lacy PE. Transplantation of intact pancreatic islets in rats. Surgery. 1972 Aug;72(2):175-86. No abstract available.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Derived from this study: PubMed 20660050Perl S, Kushner JA, Buchholz BA, Meeker AK, Stein GM, Hsieh M, Kirby M, Pechhold S, Liu EH, Harlan DM, Tisdale JF. Significant human beta-cell turnover is limited to the first three decades of life as determined by in vivo thymidine analog incorporation and radiocarbon dating. J Clin Endocrinol Metab. 2010 Oct;95(10):E234-9. doi: 10.1210/jc.2010-0932. Epub 2010 Jul 21.
- Derived from this study: PubMed 19418039Liu EH, Digon BJ 3rd, Hirshberg B, Chang R, Wood BJ, Neeman Z, Kam A, Wesley RA, Polly SM, Hofmann RM, Rother KI, Harlan DM. Pancreatic beta cell function persists in many patients with chronic type 1 diabetes, but is not dramatically improved by prolonged immunosuppression and euglycaemia from a beta cell allograft. Diabetologia. 2009 Jul;52(7):1369-80. doi: 10.1007/s00125-009-1342-7. Epub 2009 May 6.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranganath Muniyappa, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Islet Transplantation in people with Diabetes Mellitus Type 1, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 20 Apr 2021. 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin independence (time frame: every three 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 NCT00006505, which also lists 5 linked publications.
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 20 Apr 2021.