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

NCT01206101 · Terminated

Last updated 2026-05-28

This clinical trial tests whether the drug liraglutide helps people with type 1 diabetes who have received a single-donor islet cell transplant produce insulin without needing injections.

Status Terminated Stopped early and will not restart.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 3 people

Who can join Ages 18+ · all sexes

Timeline Started 2012-03 · est. completion 2013-06

Where 16 sites · Canada, France, Germany, Switzerland, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01206101 ↗

Description as written by the study sponsor.

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.

Treatments tested

liraglutide Drug

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 Drug

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.

Main thing measured	Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 1
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01206101 ↗