Clinical Outcomes of Exenatide Versus Basal Insulin

What this study is testing ClinicalTrials.gov NCT02987348 ↗

Description as written by the study sponsor.

This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD) database analysis to compare therapy effectiveness, and cost between exenatide and basal insulin in patients with type 2 diabetes. Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels (hyperglycaemia) that can result in an increased risk of a variety of conditions including heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients may control their blood sugar by lifestyle modification (diet and exercise), ultimately most will require therapeutic intervention with regimens that increase in complexity as T2DM progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to weight loss as well as improved blood glucose control. It has also been associated with reduced heart attacks and strokes. In this study CPRD database will be used to compare outcomes for patients prescribed exenatide compared with those prescribed insulin; a more established treatment for T2DM. In particular changes from baseline in blood sugar control and weight will be considered as the primary outcomes. As the choice to treat with exenatide or insulin will be related to patient characteristics which may in themselves be associated with the outcomes of the study we aim to match study patients on some of these key variables and adjust for others in our analysis.

Treatments tested

• exenatide once weekly also known as long_acting glucagon-like peptide-1 receptor agonist Drug

  patients received exenatide once weekly treatment under their standard care, no intervention was given by the study investigator

• exenatide twice daily also known as short-acting glucagon-like peptide-1 receptor agonist Drug

  patients with exenatide twice daily treatment under their standard care, no intervention was given by the study investigator.

• basal insulin also known as long-acting insulins Drug

  patients with basal insulin treatment under their standard care, no intervention was given by the study investigator