LPS14409 - TAKE CONTROL
Research type
Research Study
Full title
TAKE CONTROL: A 24-Week, Multicentre, Randomized, Open-Label, 2-Arm Parallel-group study evaluating the Efficacy and Safety of Patient-versus Physician-managed Titration of Insulin Glargine U300 in Type 2 Diabetes Mellitus (LPS14409)
IRAS ID
191553
Contact name
Melanie Davies
Contact email
Sponsor organisation
Aventis Pharma Limited, trading as Sanofi
Eudract number
2015-001626-42
Duration of Study in the UK
1 years, 2 months, 5 days
Research summary
Diabetes is a lifelong condition that causes a patient’s blood sugar to become too high. Type 2 diabetes mellitus (T2DM) 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 T2DM is diet, followed by tablets and/or injectable glucose lowering treatments.
Despite such treatment the blood sugar in patients with T2DM 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).
The purpose of this study is to compare the efficacy and safety of a titration algorithm managed by the patient with a titration algorithm managed by the physician, for administration of U300 (Toujeo) once-daily, in patients with T2DM inadequately controlled on anti-diabetic regimens.
Empowering patients to self-manage their insulin therapy has proven to be safe and sometimes more efficient than physician-managed titration in previous studies with other insulin products, comparing these 2 treatment algorithm approaches.
Patients with T2DM diagnosed for at least 1 year treated with 1 or more than 1 non-insulin antihyperglycemic drug(s)with or with a basal insulin, for a least 6 months are eligible for this study.
This study will be conducted at 10 NHS institutions throughout the UK. Patients will be on treatment for a maximum duration of 28 weeks. A total of 592 patients will participate globally.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0006
Date of REC Opinion
3 Feb 2016
REC opinion
Further Information Favourable Opinion