Faster insulin aspart (Fiasp) is used in connection to food consumption by people with type 1 diabetes mellitus (T1DM) and by people with type 2 diabetes mellitus (T2DM). The purpose of a mealtime insulin like Fiasp is to mimic the body’s mealtime insulin secretion and action as it occurs in healthy individuals, thus helping to maintain good blood glucose control in connection with meals. Good blood glucose control minimises the risk of hyperglycaemia and long-term complications. Fiasp is safe and effective in reducing blood glucose levels in people with diabetes, but the knowledge originates primarily from clinical trials carried out in controlled settings and in specific populations. Little is known about how effective Fiasp is in a real-world setting such as in patients attending normal everyday clinical practice. We propose to study blood glucose control in T1DM and T2DM first time users of Fiasp and compare them with patients on a different mealtime insulin. By using routinely collected health information the change in blood glucose levels can be investigated in patients prescribed Fiasp for the first time by their general practitioner in England. The study will provide insights to the knowledge gap about the effect of Fiasp on controlling blood glucose levels and the occurrence of low blood glucose levels in T1DM and T2DM patients using Fiasp relative to using other rapid-acting mealtime insulins in a real-world setting.
This study aims to compare the treatment effectiveness on glycaemic control of first time use of the ultra-rapid acting insulin Fiasp with rapid-acting bolus insulins in T1DM and T2DM patients living in England. Furthermore, we will investigate the change in the rate of hypoglycaemia after treatment initiation. Fiasp has proven efficacious at controlling glycaemic levels in T1DM and T2DM patients, however, limited real-world evidence is available describing the effectiveness of Fiasp compared to rapid-acting insulins. The study will use a retrospective cohort design, with the first time prescription date of Fiasp as index, to compare the effect on glycaemic control based on HbA1c concentrations prior to index and during a 12-month post-index follow-up period. Propensity score matching 1:1 will be used to allocate patients to treatment arms. Mixed model of repeated measures (MMRM) will be used to evaluate mean HbA1c levels from baseline to end of follow-up and change in HbA1c from index to 26 weeks post index. The frequency of hypoglycaemia will be evaluated by comparing the rate of hypoglycaemia prior to index with the rate of hypoglycaemia during follow-up for T1DM and T2DM, respectively, using a negative binomial regression model with a log-transformed follow-up time offset term. Treatment persistency will be evaluated by a Cox Proportional Hazard model estimating the hazard ratio for time‐to‐discontinuation of the first prescribed bolus insulin. This study will provide knowledge on the effectiveness of Fiasp treatment in T1DM and T2DM patients relative to a rapid-acting insulin treatment regimen in a real-world setting.
Glycaemic control; hypoglycaemia; treatment persistency
Uffe Christian Braae - Chief Investigator - Novo Nordisk A/S
Uffe Christian Braae - Corresponding Applicant - Novo Nordisk A/S
Amra Ciric Alibegovic - Collaborator - Novo Nordisk A/S
Anders Boeck Jensen - Collaborator - Novo Nordisk A/S
Melanie Davies - Collaborator - University of Leicester
Pranav Kelkar - Collaborator - Novo Nordisk A/S
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk A/S
Usha Thamattoor - Collaborator - Novo Nordisk A/S