Phase 2 N=14 Treatment

Islet Allotransplantation With Steroid Free Immunosuppression

Type 1 Diabetes · Hypoglycemia · Metabolic Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00446264 ↗

Enrolled (actual)

Serious AEs

85.7%

Results posted

May 2010

Primary outcome: Primary: Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year — 71 Percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: islet transplantation (Procedure); daclizumab - sirolimus - tacrolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital, Lille
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year	71	—
SECONDARY Hypoglycemic Events	—	—
SECONDARY Plasma C-peptide	1.7	—
SECONDARY HbA1c < 6.5%	64.3	—
SECONDARY Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)	11.37	—
SECONDARY Number of Adverse Events	33	—

Summary

The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected. This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

Eligibility Criteria

Inclusion Criteria

type 1 diabetes documented for more than 5 years
arginine stimulated C-peptide lower than 0.2 ng/mL
one of the following: hypoglycemia unawareness OR metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year.

Exclusion Criteria

body mass index greater than 28 kg/m2
non stable arteriopathy or heart disease
active infection
previous transplantation
hyperimmunization
insulin daily needs above 1.2 U/Kg
creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d
malignancy
smoking
desire for pregnancy
psychiatric disorders
lack of compliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00446264). 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.