NCT01206101|TerminatedPhase 2Results

Study 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.

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN2211-36192009-013090-18U1111-1114-8952

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredSep 2010

StartedMar 2012

CompletionJun 2013

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2 diabetes

Timeline

Completed

Started Mar 2012

Geographic Reach

6 countries

16 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

September 20, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed

1.5 years until next milestone

Study Start

First participant enrolled

March 21, 2012

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed

Last Updated

March 30, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

September 20, 2010

Results QC Date

June 2, 2014

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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.
At week 52 after initial transplantation

Secondary Outcomes (5)

Number of Hypoglycaemic Episodes
During week 0 to week 52
Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events
From week 0 to week 52 after initial transplantation
Proportion of Insulin-Independent Subjects
At 52 weeks after initial transplantation
Change in Islet Cell Yield During Culture
From 0 hours pre-culture to 24 hours to 72 hours
Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)
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)

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutideDrug: placebo

Liraglutide placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

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.

Liraglutide

placeboDRUG

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.

LiraglutideLiraglutide placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.