EDITION JUNIOR
Research type
Research Study
Full title
6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents age 6 - 17 Years with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period
IRAS ID
196670
Contact name
Gerry Rayman
Contact email
Sponsor organisation
sanofi-aventis recherche & développement
Eudract number
2015-002084-42
Clinicaltrials.gov Identifier
112400, IND number
Duration of Study in the UK
1 years, 10 months, 11 days
Research summary
Since Insulin glargine U100 (Lantus) is approved for children with Type 1 diabetes mellitus (T1DM), it is hoped that HOE901-U300 (a new formulation of insulin glargine with same composition but 3-times the amount of active insulin) may also be used in T1DM. This study is planned to compare the effectiveness and safety of both treatments.
HOE901-U300 (Toujeo) was approved in the European Union on April 12, 2015 for the treatment of adults with diabetes.
After consent / assent, children will be randomly placed in one of two groups (1:1) to receive HOE901-U300 or Lantus.
Children will be asked to attend the study centre with their carers for 7 visits and to have 13 telephone call over 13.5 months (approx. 6-month treatment, 6-month safety extension and 4 week post-treatment visit after return to a commercially available basal insulin).
The main goal of the study is to compare both treatments regarding how well they help the children to keep their diabetes in control by measuring the change in glycated haemoglobin A1c (HbA1c, which measures how well the blood sugars have been controlled) from baseline to six months.
Children will need to have had T1DM for at least one year and be willing to test and record their blood sugars in a similar way to those done in standard care but will have extra contact with their study teams to ensure the best control possible.
Children will need to have various blood samples taken but this has been minimised as much as possible to reduce discomfort but still to meet regulatory requirements.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0175
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion