Phase 2
N=8
Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00133809 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Jun 2016
Primary outcome: Primary: The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Transplantation of Human Islets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation |
5 | — |
| SECONDARY Number of Insulin-independent Subjects Following Islet Transplantation |
6; 6; 6; 6; 5; 5 | — |
| SECONDARY Number of Subjects With HbA1C ≤ 6.5% |
6; 7; 8; 8; 8; 8 | — |
| SECONDARY The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL |
6; 6; 6; 6; 5; 5 | — |
Summary
This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness, or recurrent hyperglycemia with ketoacidosis.
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus diagnosed > 5 years previously
- Body mass index less than or equal to 26
- 18 to 65 years of age
- Compliance with an optimized diabetic management plan as assessed by an Emory University endocrinologist
- Checking and recording blood sugars at least 3 times per day
- Intensive insulin therapy (injecting insulin at least 3 times a day or using an insulin pump)
- Severe hypoglycemia and/or hyperglycemia. Severe hypoglycemia is defined by: episodes requiring assistance by others and/or hypoglycemic unawareness (the inability to recognize blood glucose 20%
- Active peptic ulcer disease
- Evidence of gallbladder disease including cholecystitis and cholelithiasis
- Evidence of liver disease including hepatic neoplasm, portal hypertension, or persistently abnormal liver function tests.
- Persistent coagulopathy or current use of anticoagulants (not including aspirin)
- Sickle cell anemia
- Positive pregnancy test, intent for future pregnancy, failure to follow effective contraceptive measures, or presently breastfeeding
- Active alcohol or substance abuse. This includes smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current National Institute on Alcohol Abuse and Alcoholism (NIAAA) definitions.
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- Current use of systemic steroid medications
- Evidence of insulin resistance (insulin requirement > 1.2 units/kg/day)
- Inability to provide informed consent
- Any condition or any circumstance that makes it unsafe to undergo an islet transplant
Data sourced from ClinicalTrials.gov (NCT00133809). 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.