Clinical trial NCT01206101: Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
Official title: A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 5 years
* Candidate for islet cell transplantation based upon local accepted practice and guidelines
* Reduced awareness of hypoglycaemia

Exclusion Criteria:

* Treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start
* Any previous organ transplantation
* A history of acute idiopathic or chronic pancreatitis
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

Primary outcomes:
measure: Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant
timeFrame: At week 52 after initial transplantation
Secondary outcomes:
measure: Number of Hypoglycaemic Episodes
timeFrame: During week 0 to week 52
measure: Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events
timeFrame: From week 0 to week 52 after initial transplantation
measure: Proportion of Insulin-Independent Subjects
timeFrame: At 52 weeks after initial transplantation
measure: Change in Islet Cell Yield During Culture
timeFrame: From 0 hours pre-culture to 24 hours to 72 hours
measure: Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)
timeFrame: At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Madison
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Besancon
country: France
facility: Novo Nordisk Investigational Site
city: Grenoble
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Genève 14
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Headington
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: