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

This study has been terminated.
(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.)
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: September 20, 2010
Last updated: January 3, 2014
Last verified: December 2013

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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: liraglutide
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Proportion of insulin-independent subjects after receiving only one (single-donor) islet cell transplant [ Time Frame: at week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hypoglycaemic episodes [ Time Frame: During weeks 0-52 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HbA1c below or equal to 6.5% at week 52 that are free from severe hypoglycaemic events [ Time Frame: From week 0 to week 52 after initial transplantation ] [ Designated as safety issue: No ]
  • The proportion of insulin independent subjects [ Time Frame: at 52 weeks after initial transplantation among all randomised subjects having one or more transplantations after randomisation. ] [ Designated as safety issue: No ]
  • Change in islet cell yield during culture [ Time Frame: From (0 hours) pre-culture to (24 to 72 hours) post-culture ] [ Designated as safety issue: No ]
  • Glucose level variability and hypoglycaemia duration derived from the continuous glucose monitoring system (CGMS) [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide Drug: liraglutide
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.
Placebo Comparator: Liraglutide placebo Drug: placebo
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206101

United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53792-0001
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2C8
Strasbourg, France, 67091
Dresden, Germany, 01307
Genève 14, Switzerland, 1211
United Kingdom
Headington, United Kingdom, OX3 7LE
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Birgitte Claudius Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01206101     History of Changes
Other Study ID Numbers: NN2211-3619, 2009-013090-18, U1111-1114-8952
Study First Received: September 20, 2010
Last Updated: January 3, 2014
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014