Most patients with the metabolic disorder type 2 diabetes mellitus (T2DM), that leads to elevated blood glucose (BG) levels, will at some point require treatment with insulin to control BG levels. Good BG control minimises the risk of long-term complications of T2DM but is associated with increased risk of periodic low BG levels and weight gain. Biphasic Insulin Aspart 30/70 (BIAsp 30) is safe and effective in reducing BG levels in T2DM patients. However, there is limited real-world evidence as to the effect of BIAsp 30 used in combination with GLP-1 treatment on BG control. We propose to study BG control in T2DM first time users of BIAsp 30 in combination with GLP-1 and compare them with patients on a first time basal insulin and GLP-1 regimen. By using routinely collected health information, the change in BG levels can be investigated in patients prescribed BIAsp 30 and GLP-1 simultaneously for the first time by their general practitioner in England. The study will provide insights to the knowledge gap about the effect of BIAsp 30 in combination with GLP-1 on controlling BG levels, weight change, and the occurrence of low BG levels in T2DM patients using this combination.
This study aims to compare the effect on glycaemic control of first time combined use of BIAsp 30 and GLP-1 with first time combined use of modern basal insulin and GLP-1 in T2DM patients living in England. Furthermore, we will investigate the change in weight and the rate of hypoglycaemia after treatment initiation. BIAsp 30 is effective in controlling glycaemic levels in T2DM patients, however, limited evidence is available describing the relative effect when combined with GLP-1 compared to modern basal insulin and GLP-1 treatment in a real-world setting. The study will use a retrospective cohort design, with the first time combined treatment of insulin and GLP-1 date as index, to compare effect on glycaemic control based on HbA1c concentrations prior to index and during a 12-month post-index follow-up period. Propensity score matching will be used to match patients between 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. Identical methodology will be used to examine change in mean BMI. The risk of hypoglycaemia will be evaluated by comparing the rate of hypoglycaemia prior to index with the rate of hypoglycaemia during follow-up using a negative binomial regression model with a log-transformed follow-up time offset term. The study will provide knowledge on the effect of combined treatment of BIAsp 30 and GLP-1 on glycaemic control relative to basal insulin in combination with GLP-1 treatment in a real-world setting.
Glycaemic control; weight/BMI; hypoglycaemia
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
Gayathri Anil - Collaborator - Novo Nordisk A/S
Melanie Davies - Collaborator - University of Leicester
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk A/S