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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01206101
• Other study ID #: NN2211-3619
• Secondary ID: 2009-013090-18U1
• Status: Terminated
• Phase: Phase 2
• First received: September 20, 2010
• Last updated: June 2, 2014
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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
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.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Hypoglycaemic Episodes	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).	During week 0 to week 52	No
Secondary	Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events	Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events	From week 0 to week 52 after initial transplantation	No
Secondary	Proportion of Insulin-Independent Subjects	Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation	At 52 weeks after initial transplantation	No
Secondary	Change in Islet Cell Yield During Culture	Change in islet cell yield from pre-culture to post-culture	From 0 hours pre-culture to 24 hours to 72 hours	No
Secondary	Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)	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)	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)	No

External Links

•   Clinical Trials at Novo Nordisk