LPS13931: Outcomes in insulin naïve patients with uncontrolled T2DM
Research type
Research Study
Full title
A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of Toujeo® compared to standard of care insulin for initiating basal insulin in insulin naïve patients with uncontrolled type 2 diabetes mellitus, with 6-month extension.
IRAS ID
183760
Contact name
John Wilding
Contact email
Eudract number
2015-001831-18
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Diabetes is a lifelong condition that causes a patient’s blood sugar to become too high. Type 2 diabetes (T2D) occurs when the body doesn't produce enough insulin to function properly, or the body’s cells don't react to insulin. This is known as insulin resistance. Initial treatment for T2D is diet, followed by tablets and/or injectable glucose lowering treatments.
Despite such treatment the blood sugar in patients with T2D tends to increase over time, and treatment with insulin (injected once or twice a day) is required.
U300 insulin glargine (U300) is a new insulin, given once daily. It is a more concentrated insulin, with a lower volume of injection that provides a smoother, more stable uptake of insulin than other forms of insulin, potentially reducing the risk of low blood sugar (hypoglycaemia).
This trial will compare U300 together with its dedicated patient support programme, to other types of insulin that are currently used as standard care (with their patient support programmes, if available); these programmes provide education about diabetes, insulin treatment and help guide dose adjustment to optimise blood sugar control.
The primary aim is to show that after 6 months of treatment, Toujeo is at least as good as (‘non-inferior to) standard care, as measured by HbA1c, the usual method of assessing long-term sugar control in clinical practice.
The study will also look at blood sugar control compared to standard care over 6 and 12 months of treatment and patient’s experiences on treatment including incidence (frequency) of hypoglycaemic events.
Patients who agree to participate and meet the entry criteria will be allocated at random to either U300 or standard care insulin. A total of 680 people with type 2 diabetes will enter the study, half will be treated with U300, and half will receive standard care insulin.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0697
Date of REC Opinion
3 Nov 2015
REC opinion
Further Information Favourable Opinion