LPS14584 - Toujeo vs Tresiba in T2DM
Research type
Research Study
Full title
A 24-Week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
IRAS ID
201450
Contact name
Jeffrey Stephens
Contact email
Eudract number
2015-005101-36
Research summary
In many patients the progressive nature of type 2 diabetes requires introducing insulin therapy at a certain stage of
their disease. Clinicians face challenges when advising patients to start insulin: fear of pain and needles, concerns of
side effects of insulin (ie, hypoglycemia, weight gain etc) and the complexity of delivering the insulin despite marked
improvement in the delivery process. Toujeo and Tresiba are two recently approved basal insulins introduced to
clinical practise to address some of these issues.
The main goal of this study is to compare the long-acting basal insulins, Toujeo and Tresiba regarding how well they
help the subjects to keep their diabetes in control by measuring the change in glycated haemoglobin (HbA1c, which
measures how well the blood sugars have been controlled) from baseline to six months.
Participants will need to have had type 2 diabetes 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.
participants will need to have various blood samples taken but this has been minimised as much as possible to
reduce discomfort while still meeting regulatory requirements.
After consent participants will be placed in one of two groups (1:1) to receive either Toujeo or Tresiba. Participants will
be asked to attend the study centre for 9 visits and to have 12 telephone calls over 7.5 months (2 week screening period, 24 weeks treatment period and 1 week follow-up visit).REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0223
Date of REC Opinion
28 Jun 2016
REC opinion
Further Information Favourable Opinion