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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.)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01206101
First received: September 20, 2010
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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
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 after initial transplantation ] [ Designated as safety issue: No ]
    Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.


Secondary Outcome Measures:
  • Number of Hypoglycaemic Episodes [ Time Frame: During week 0 to week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From week 0 to week 52 after initial transplantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 52 weeks after initial transplantation ] [ Designated as safety issue: No ]
    Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation

  • Change in Islet Cell Yield During Culture [ Time Frame: From 0 hours pre-culture to 24 hours to 72 hours ] [ Designated as safety issue: No ]
    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) [ 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) ] [ Designated as safety issue: No ]
    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)


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206101

Locations
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53792-0001
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2C8
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry GCR, 1452 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
Results First Received: June 2, 2014
Last Updated: June 2, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 24, 2014