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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01206101
• Date of registration: 20/09/2010
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
• Scientific 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
• Date of first enrolment: March 21, 2012
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01206101
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, France, Germany, Switzerland, United Kingdom, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Diabetes

Intervention(s)

Drug: liraglutide

Drug: placebo

Primary Outcome(s)

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant [Time Frame: At week 52 after initial transplantation]

Secondary Outcome(s)

Number of Hypoglycaemic Episodes [Time Frame: During week 0 to week 52]

Change in Islet Cell Yield During Culture [Time Frame: From 0 hours pre-culture to 24 hours to 72 hours]

Proportion of Insulin-Independent Subjects [Time Frame: At 52 weeks after initial transplantation]

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]

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)]

Secondary ID(s)

U1111-1114-8952

2009-013090-18

NN2211-3619

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/07/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01206101