LEA29Y (Belatacept) Emory Edmonton Protocol

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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 and effectiveness of islet transplantation using a steroid-free, calcineurin-inhibitor-free belatacept based immunosuppressive medication, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Key facts

Study ID

NCT00468403

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

10

Starts

2008-10-01

Expected to finish

2013-04-01

Last updated by the study team

2016-04-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mentally stable and able to comply with study procedures
• Clinical history compatible with type 1 diabetes with onset of disease 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 no less than a mean of three times each day averaged over each week
• Three or more insulin injections each day or insulin pump therapy
• Under the care of an endocrinologist, diabetologist, or diabetes specialist with at least three clinical evaluations during the past 12 months prior to study enrollment
• At least one episode of severe hypoglycemia, defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the participant was unable to treat him/herself and which was associated with either a blood glucose level less than 54 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagons in the 12 months prior to study enrollment
• Reduced awareness of hypoglycemia. More information about this criterion is in the protocol.

You may not qualify if…

• Body mass index (BMI) greater than 30 kg/m\^2 or weight less than or equal to 50 kg (110 lbs)
• Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day
• 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 using iohexol of less than 80 mL/min/1.73m\^2.
• Presence or history of macroalbuminuria (greater than 300 mg/g creatinine)
• Presence or history of panel-reactive anti-Histocompatibility Antigen (HLA) antibody levels greater than 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
• All women more than 35 years and women of any age who have first degree relatives with a history of breast carcinoma or who have other risk factors of breast carcinoma. More information about this criterion is in the study protocol.
• Active infection, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV). Presence or history of tuberculosis. More information about these criteria is in the protocol.
• Negative for Epstein-Barr virus (EBV) by anti-viral capsid antigen (VCA) IgG (EBV VCA-IgG) determination
• Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection in the past year
• History of malignancy except for completely resected squamous or basal cell carcinoma of the skin
• Known active alcohol or substance abuse
• Baseline 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 international normalized ratio (INR) greater than 1.5.
• Severe coexisting cardiac disease, defined as:
• 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 study entry
• Symptomatic cholecystolithiasis
• Acute or chronic pancreatitis

Where it is running

• Emory University — Atlanta, Georgia, United States
• University of Alberta — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.