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Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide

Liraglutide placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant
Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.

Secondary Outcome Measures

Number of Hypoglycaemic Episodes
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).
Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events
Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events
Proportion of Insulin-Independent Subjects
Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation
Change in Islet Cell Yield During Culture
Change in islet cell yield from pre-culture to post-culture
Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)
Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, 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)

Full Information

First Posted
September 20, 2010
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01206101
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The decision to close the NN2211-3619 trial was based on the very low recruitment rate as well as challenges relating to trial execution and study completion.
Study Start Date
March 21, 2012 (Actual)
Primary Completion Date
June 3, 2013 (Actual)
Study Completion Date
June 3, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Title
Liraglutide placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.
Primary Outcome Measure Information:
Title
Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant
Description
Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.
Time Frame
At week 52 after initial transplantation
Secondary Outcome Measure Information:
Title
Number of Hypoglycaemic Episodes
Description
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).
Time Frame
During week 0 to week 52
Title
Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events
Description
Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events
Time Frame
From week 0 to week 52 after initial transplantation
Title
Proportion of Insulin-Independent Subjects
Description
Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation
Time Frame
At 52 weeks after initial transplantation
Title
Change in Islet Cell Yield During Culture
Description
Change in islet cell yield from pre-culture to post-culture
Time Frame
From 0 hours pre-culture to 24 hours to 72 hours
Title
Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)
Description
Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, 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)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MONTPELLIER cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Genève 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Headington
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

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