Phase 2 N=36 Treatment

Islet Transplantation for Type 1 Diabetes

Diabetes Mellitus, Insulin-Dependent

Bottom Line

View on ClinicalTrials.gov: NCT00014911 ↗

Enrolled (actual)

Serious AEs

47.2%

Results posted

Oct 2012

Primary outcome: Primary: Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. — 44; 14; 17; 14 Percent of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Islet Transplantation (Procedure); Sirolimus (Drug); Tacrolimus (Drug); Daclizumab (Drug); Sulfamethoxazole (Drug); Ganciclovir (Drug); Trimethoprim (Drug); Pentamidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Jun 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation.	44; 14; 17; 14	—
SECONDARY Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.	28	—
SECONDARY Percent of Participants That Achieved Insulin Independence From First Transplant	58	—
SECONDARY Percent of Participants With Detectable Fasting Basal C-Peptide Levels	70	—

Summary

The purpose of this study is to test whether the islet cell transplantation procedures and results from a previous study in Edmonton, Canada, can be repeated. The study also is designed to learn more about diabetes control using islet cell transplantation. This is a Phase I/II study (a study that examines effectiveness and looks for side effects). The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression.

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Have had Type 1 diabetes mellitus for more than 5 years, and are exhibiting 1 of the following, despite intensive insulin management efforts: a) hypoglycemic unawareness, as defined by inability to sense hypoglycemia until the blood glucose falls to less than 54 mg/dL; b) metabolic instability, with 2 or more episodes of severe hypoglycemia (defined as an event with symptoms consistent with hypoglycemia in which the patient requires the assistance of another person and which is associated with a blood glucose below 54 mg/dL) or 2 or more hospital visits for diabetic ketoacidosis over the last year; or c) despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by retinopathy, nephropathy, or neuropathy.
Are 18 to 65 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have had severe cardiac disease as defined by: a) recent myocardial infarction within the past 6 months; b) angiographic evidence of non-correctable coronary artery disease; or c) evidence of ischemia on a functional cardiac exam.
Actively abuse alcohol or substances, including cigarette smoking (must not have smoked within the last 6 months).
Have psychiatric problems that prevent them from being a suitable candidate for transplantation (such as schizophrenia, bipolar disorder, or major depression that is not controlled or stable on current medication).
Have a history of not following prescribed regimens.
Have active infection including hepatitis C virus, hepatitis B virus, human immunodeficiency virus (HIV), or Tuberculosis (TB) (or under treatment for suspected TB).
Have a history of malignancy, except squamous or basal skin cancer.
Weigh more than 70 kilograms or have a Body Mass Index (BMI) greater than 26 kg/m^2 at time of screening.
Have a C-peptide value of 0.3 ng/ml or more following a 5.0 gram intravenous arginine infusion challenge.
Are unable to provide informed consent.
Have gallstones or hemangioma in liver.
Have untreated proliferative retinopathy.
Are breast-feeding or pregnant, or intend to try and become pregnant (females) or to father a child (males), or fail to follow birth control methods.
Have had a previous transplant, or evidence of anti-human leukocyte antigen (HLA) antibody.
Have an insulin requirement of more that 0.7 International Units (IU)/kilograms/day.
Have a blood glycosylated hemoglobin (HbA1c) higher than 12 percent.
Are unable to reach the hospital for transplantation within 2 hours of notification.
Have untreated or treated hyperlipidemia.
Have a medical condition requiring chronic use of steroids.
Use coumadin or other anticoagulants (aspirin is allowed).
Have Addison's disease.
Have a negative screen for Epstein-Barr virus (EBV).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00014911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.