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

• Status: Terminated
• Trial end date: 2013-06-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

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)