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

Novo Nordisk

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01206101

2009-013090-18 (EudraCT Number)

U1111-1114-8952 (Other Identifier)

NN2211-3619

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Liraglutide

Experimental group

Treatment:

Drug: placebo

Drug: liraglutide

Liraglutide placebo

Placebo Comparator group

Treatment:

Drug: placebo