Effectiveness /safety of S95002 implant vs GLP-1 RA in T2 diabetes
Research type
Research Study
Full title
A phase IIIb, multicentre, pragmatic Randomised Controlled Trial to compare the effectiveness and safety of S95002 to other GLP-1 receptor agonists as add-on therapy to oral therapy in patients with type 2 diabetes
IRAS ID
224420
Contact name
John NEW
Contact email
Sponsor organisation
Servier Research and Development Ltd UK
Eudract number
2017-000951-13
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
This study is aiming to demonstrate the benefit of S95002 (exenatide in a mini-pump) on adherence and efficacy (or a higher proportion of patients attaining better diabetes control)long-term, compared to other GLP-1 receptor agonists (injectables) currently available in the UK, in patients with uncontrolled type 2 diabetes. Either study treatment will be given as an add-on to current oral therapy.
This UK study aims to recruit 800 patients, male or female, age at least 18. It has a pragmatic design, in that patients will have as little change to their routine diabetes care as possible, and will be required to participate in 3 study visits, selection, inclusion (M0) and month 21-visit (M021/end of study).
GLP-1 receptor agonists (GLP-1) are glucose lowering drugs which top up the level of a natural stomach hormone called Glucagon-like-peptide.
GLP-1s currently prescribed in the UK are injectable and require once, twice daily or once weekly injections. S95002 is a small titanium matchstick-like mini-pump containing the GLP-1 receptor agonist, Exenatide.
S95002 is placed sub-dermally under the skin of the abdomen in aseptic conditions where it will release Exenatide at a predetermined steady rate.10 completed / 2 ongoing studies have been conducted by Servier’s partner Intarcia, and support the positive benefit risk ratio of S95002 using the 20/60 mcg/day dose. Over 2600 patients were treated with the dosing scheme 20/60 mcg/day.
Patients will be given S95002 60 mcg/day following an introductory dose of 20 mcg/day for 3 months or an injectable GLP-1 RA (investigator’s choice including dose and dosage) over 21 months.
Efficacy will be evaluated by measuring HbA1C, any modification of anti-diabetic treatment over 21 months. Safety and tolerability evaluation is done regarding adverse events, Diabetes Treatment Satisfaction Questionnaire.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0372
Date of REC Opinion
20 Sep 2017
REC opinion
Further Information Favourable Opinion