Glycaemic Control in Type 2 Diabetes Patients after Switching from Basal-Bolus Treatment to Biphasic Insulin Aspart 30/70: a Descriptive Study

Date of ISAC Approval: 
Lay Summary: 
Type 2 diabetes mellitus (T2DM) is a serious disease where blood sugar levels are too high. As the disease progress, patients often require treatment with two types of insulin products known as rapid- and long-acting insulin, respectively. Patients treated with rapid- and long-acting insulins experience a large burden having to administer three to four injections per day. Not all patients with T2DM are able or willing to cope with the complexity of an intensive treatment like this and are therefore switched to a more convenient product known as premix insulin. Premixed insulin is a combination of rapid- and long-acting insulin offering the convenience of only twice daily insulin injections, while avoiding administration errors inherent in mixing separate insulins or giving multiple separate injections. Biphasic Insulin Aspart 30/70 (BIAsp 30) is a type of premixed insulin. There is limited data on clinical characteristics and blood sugar levels in patients switching to BIAsp 30 in clinical practise. We propose to study blood sugar control in patients prescribed BIAsp 30 by their general practitioner in the UK. By using routinely collected health information from the Clinical Practice Research Datalink (CPRD) we will determine T2DM patients treated with multiple daily insulin injections switching to BIAsp 30 and examine blood sugar levels before and after switching. Furthermore, we will investigate clinical characteristics. The study will help fill in the knowledge gap about clinical characteristics and blood sugar levels in patients switching to BIAsp 30 in real world clinical practise.
Technical Summary: 
Premixed insulins offer the convenience of fewer daily injections and better adherence in T2DM patients requiring both fast- and long-acting insulin treatment. Clinical trials have found the treatment effect to be comparable to basal-bolus treatment, however little is known about glycaemic control in patients switching from basal-bolus treatment to Biphasic Insulin Aspart 30/70 (BIAsp 30) in the real world. This study aims to investigate glycaemic control and other clinical characteristics in T2DM patients switching from basal-bolus treatment to BIAsp 30 in a population-based study in the UK. Data will be extracted from the CPRD database allowing for an analysis of the effect of switching to BIAsp 30 in a real-world setting. BIAsp 30 naiive patients will be followed after switching from basal-bolus treatment and their change in HbA1c will be analysed using a mixed model of repeated measures (MMRM). Treatment adherence will be evaluated by analysing the time until discontinuation. The study will provide knowledge of glycaemic control and clinical characteristics in T2DM patients switching from basal-bolus to BIAsp 30 in the real world.
Health Outcomes to be Measured: 
HbA1c over time; weight over time; discontinuation of BIAsp 30; BMI at index date; diabetes duration at index date; previous basal insulin treatment; previous bolus insulin treatment; concomitant bolus insulin treatment; history of hypoglycaemia; incidence of hypoglycaemia.

Dr Uffe Christian Braae - Chief Investigator - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Anders Boeck Jensen - Collaborator - Novo Nordisk
Dr Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Professor Melanie Davies - Collaborator - University of Leicester
Pranav Kelkar - Collaborator - Novo Nordisk