Status:
COMPLETED
Strategies to Improve Islet Survival
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety...
Detailed Description
Type 1 diabetes is commonly treated with the administration of insulin, either by multiple insulin injections or by a continuous supply of insulin through a wearable pump. Insulin therapy allows for l...
Eligibility Criteria
Inclusion
- Mentally stable and able to comply with study procedures
- Clinical history compatible with type 1 diabetes with onset at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28
- Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test
- Involvement of intensive diabetes management, defined as:
- Self-monitoring of glucose values no less than a mean of three times each day averaged over each week
- Administration of three or more insulin injections each day or insulin pump therapy
- Under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least three evaluations during the 12 months prior to study enrollment
- At least one episode of severe hypoglycemia in the past 12 months prior to study enrollment
- Reduced awareness of hypoglycemia. More information about this criterion, including specific definition of hypoglycemia unawareness, is in the protocol.
Exclusion
- Body mass index (BMI) greater than 30 kg/m\^2 or weight less than or equal to 50 kg
- Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day
- Hemoglobin A1C (HbA1c) greater than 10%
- Untreated proliferative diabetic retinopathy
- Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg
- Measured glomerular filtration rate (GFR) using iohexol of less than 80 mL/min/1.73m2. More information about this criterion is in the protocol.
- Presence/history of macroalbuminuria (greater than 300 mg/g creatinine)
- Presence/history of panel-reactive anti-HLA antibodies above background by flow cytometry. More information about this criterion is in the protocol.
- Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion
- Presence of history of active infection, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis (TB). More information about this criterion is in the protocol.
- Negative for Epstein-Barr virus (EBV) by IgG determination
- Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment
- History of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Known active alcohol or substance abuse
- Baseline hemoglobin (Hgb) below the lower limits of normal, lymphopenia, neutropenia, or thrombocytopenia
- History of Factor V deficiency
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or individuals with an INR greater than 1.5
- Severe coexisting cardiac disease, characterized by any one of the following conditions:
- Heart attack within the last 6 months
- Evidence of ischemia on functional heart exam within the year prior to study entry
- Left ventricular ejection fraction less than 30%
- Persistent elevation of liver function tests at the time of study entry
- Symptomatic cholecystolithiasis
- Acute or chronic pancreatitis
- Symptomatic peptic ulcer disease
- Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with the ability to absorb oral medications
- Hyperlipidemia despite medical therapy (fasting low-density lipoprotein \[LDL\] cholesterol \> 130 mg/dL, treated or untreated; and/or fasting triglycerides \> 200 mg/dL)
- Receiving treatment for a medical condition that requires chronic use of systemic steroids, except for the use of 5 mg or less of prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only
- Treatment with antidiabetic medication other than insulin within the past 4 weeks
- Use of any study medications within the past 4 weeks
- Received a live attenuated vaccine(s) within 2 months of enrollment
- Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial
- Treatment with any immunosuppressive regimen at the time of enrollment
- A previous islet transplant
- A previous pancreas transplant, unless the graft failed within the first week due to thrombosis, followed by pancreatectomy and the transplant occurred more than 6 months prior to enrollment
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00464555
Start Date
December 1 2006
End Date
February 1 2014
Last Update
April 26 2016
Active Locations (2)
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1
University of Miami
Miami, Florida, United States
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60607