Abstract body
Background

Non-adherence to type 2 diabetes (T2D) medications contributes significantly to poor glycaemic control, and results in increased morbidity, mortality, and healthcare costs. Drug delivery with ITCA 650, a sub-dermally placed osmotic mini-pump delivering continuous subcutaneous exenatide for up to 6 months, does not require any action by the patient to ensure medication adherence, maximizing the potential to realize the full therapeutic efficacy of exenatide. A real-world setting is the ideal environment to capture any potential clinical benefits associated with ITCA 650 over the long term.

CLINICAL TRIALS REGISTRATION NUMBER: EudraCT number 2017‐000951‐13

Aim

The aim of this study is to explore the potential benefit on long-term effectiveness of ITCA 650 compared with other GLP-1 receptor agonists (RAs), given as add-on therapy in patients with T2D inadequately controlled with two existing oral hypoglycaemic agents.

Method

This pragmatic Randomized Controlled Trial (pRCT) in adult patients with T2D will evaluate the clinical effectiveness and safety of ITCA 650 vs physician’s choice of GLP-1 RAs currently available in the UK. Data will be captured on glucose control, body weight, adherence, safety, healthcare resource utilization.

Results

PRIMARY EFFECTIVENESS ENDPOINT:

The primary endpoint is a composite variable that defines achievers as patients who satisfy both of the following criteria:

  1.  1. HbA1c <53 mmol/mol (<7.0%) or reduction from baseline in HbA1c at ≥11 mmol/mol (≥1%) at 21 months,

2. No modification of anti-diabetic treatment over 21 months specifically, no addition of a new drug class, switch to a new drug class, discontinuation of the study treatment (GLP-1 RA or ITCA 650), or dose increase of the background oral treatment compared to baseline dose.

This study will utilize linked data systems developed by North West E-Health (NWEH, Manchester, UK) that connect multiple National Health Services information sources and facilitates near to real-time collection and remote monitoring of safety data.

Discussion

This study will be the first pRCT of a diabetes medication initiated prior to regulatory approval. Use of NWEH systems to monitor safety and collect clinical endpoints offers minimal disruption to patients and permits the trial to be performed in an environment that mimics use of these medicines in the real world. This innovative study will assess the clinical, economic, and patient-reported impact of the novel mode of administration of ITCA 650 in patients with T2D as compared with other GLP-1 RAs.

Effectiveness and safety of ITCA 650 vs currently available GLP-1 RAs in type 2 diabetes: a phase IIIb, pragmatic RCT