Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | March 2012 |
| End Date: | January 2015 |
| Contact: | Novo Nordisk Clinical Trial Call Center |
| Phone: | 866-867-7178 |
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
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.
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)
We found this trial at
4
sites
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