4150: NNC0114-0006 and liraglutide in newly diagnosed type 1 diabetes
Research type
Research Study
Full title
A randomised, double-blind, double-dummy, placebo-controlled, parallel-group multi-centre clinical proof-of-principle trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of NNC0114-0006 and liraglutide on preservation of beta-cell function
IRAS ID
185435
Contact name
Shenaz Ramtoola
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2014-001215-39
Clinicaltrials.gov Identifier
U1111-1154-7172, UTN
Duration of Study in the UK
3 years, 1 months, 8 days
Research summary
This study is looking at the effect of a new treatment for patients newly diagnosed with type 1 diabetes. In type 1 diabetes, the body does not produce or only produces a limited amount of insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy. Insulin is produced in cells called beta-cells which are located in the pancreas. At the time of diagnosis with type 1 diabetes, some beta-cells may still work but during the course of the disease they will gradually stop working.
This study will investigate if a new drug called NNC0114-0006 (Anti-IL-21) when given together with another drug marketed for type 2 diabetes called liraglutide (Victoza®) can preserve the beta-cells in subjects diagnosed with type 1 diabetes. By preserving the beta-cells we may be able to stop disease progression and to enhance the function of the remaining beta-cells in the pancreas. As it is thought that liraglutide may have a positive effect on the beta-cells, it is hoped that giving this in combination with NNC0114-0006 will increase the overall effect of the treatment. The study will be carried out in clinics around the world and plans to include 304 participants. Eligible participants will be in the study for approximately 1½ years. During this time participants will have 33 visits to the trial site and 56 phone contacts. The duration of each visit at the trial site and the length of the phone contacts may vary depending on the different assessments to be performed and the routines at the site. Participants will be randomised to 4 different treatment groups including a placebo only arm. Participants will receive intravenous infusions of anti-IL-21 (or placebo) at the trial site and will be provided with liraglutide (or placebo) to administer by subcutaneous injection every day.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0592
Date of REC Opinion
20 Aug 2015
REC opinion
Favourable Opinion