Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT01206101Other idNN2211-3619Other id2009-013090-18Other idU1111-1114-8952Other id2009

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: 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.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 3 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 6 countries
United States, Canada, France, Germany, Switzerland, United Kingdom
Start: 21 Mar 2012
Primary completion: 3 Jun 2013
Completion: 3 Jun 2013
First posted: 21 Sept 2010 (estimated)
Last update posted: 30 Mar 2017
Conditions: Diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201220132014

Ph 2
Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
NCT01206101
21 Mar 2012 to 3 Jun 2013
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

liraglutideDrug
placeboDrug

Arms2

Experimental
Liraglutide
Placebo comparator
Liraglutide placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant
Time frame · At week 52 after initial transplantation
Registry description
Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.

Secondary outcomes(5)

Number of Hypoglycaemic Episodes
Time frame · During week 0 to week 52
Registry 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).
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
Registry description
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
Registry description
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
Registry description
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)
Registry 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· At week 52 after initial transplantation

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

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Secondary and other outcome results(5)

Secondary outcome· During week 0 to week 52

Number of Hypoglycaemic Episodes

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Secondary outcome· From week 0 to week 52 after initial transplantation

Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Secondary outcome· At 52 weeks after initial transplantation

Proportion of Insulin-Independent Subjects

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Secondary outcome· From 0 hours pre-culture to 24 hours to 72 hours

Change in Islet Cell Yield During Culture

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Secondary outcome· 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)

Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)

Group	Value
Liraglutide	not posted
Liraglutide Placebo	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LiraglutideLiraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.	–	0 / 2	2 / 2
Liraglutide PlaceboLiraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.	–	0 / 1	1 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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