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

Phase 2

Terminated

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: liraglutide; Drug: placebo

• Registration Number: NCT01206101
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Study Start: 2012-03-21
• Primary Completion: 2013-06-03
• Study Completion: 2013-06-03
• Results First Submitted: 2014-06-02
• Results First Submitted QC: 2014-06-02
• Results First Posted: 2014-07-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	placebo	-
Liraglutide placebo	placebo	-
Liraglutide	liraglutide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Hypoglycaemic Episodes	During week 0 to week 52	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	From week 0 to week 52 after initial transplantation	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	At 52 weeks after initial transplantation	Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation
Change in Islet Cell Yield During Culture	From 0 hours pre-culture to 24 hours to 72 hours	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)	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 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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 London, United Kingdom