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

September 20, 2010
June 2, 2014
March 2012
June 2013   (final data collection date for primary outcome measure)
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.
Proportion of insulin-independent subjects after receiving only one (single-donor) islet cell transplant [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01206101 on ClinicalTrials.gov Archive Site
  • 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)
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: during weeks 0-52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • 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.
  • 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.
  • Experimental: Liraglutide
    Intervention: Drug: liraglutide
  • Placebo Comparator: Liraglutide placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Switzerland,   United States
 
NCT01206101
NN2211-3619, 2009-013090-18, U1111-1114-8952
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry GCR, 1452 Novo Nordisk A/S
Novo Nordisk A/S
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP