Retrospective cohort study on first-time use of insulin detemir for diabetes type 2 glycaemic control in elderly and multimorbidity patients living in the United Kingdom

Date of ISAC Approval: 
Lay Summary: 
Type 2 diabetes (T2DM) is a metabolic disorder that leads to elevated blood sugar levels, which over time can result in complications such as eye, kidney, liver, or cardiovascular problems. As the disease progress, patients often require treatment with insulin to control blood sugar levels, which in turn minimises the risk of long-term complications, but is associated with increased risk of low blood sugar levels. Insulin detemir has proved to be safe and effective in reducing blood sugar levels in T2DM patients. However, there is limited evidence as to the effect of insulin detemir in specific T2DM populations such as the elderly and patients suffering from comorbidities such as cardiovascular, kidney, or liver disease. We propose to study blood sugar control in T2DM first-time users of insulin detemir that are elderly or suffering from comorbidities. This will be evaluated using the health information data collected from CPRD of first time insulin detemir users belonging to the above mentioned patient groups. By using routinely collected health information the change in blood glucose levels can be investigated in patients prescribed insulin detemir for the first time by their general practitioner in the United Kingdom. The study will provide insights to the knowledge gap about the effect of insulin detemir on controlling blood sugar levels and the occurrence of low blood sugar levels in elderly patients and with patients with multimorbidity in a real world setting.
Technical Summary: 
This study aims to describe the change in HbA1c levels in T2DM patient groups such as elderly (>/=65) and patients with comorbidities such as cardiovascular, renal, or liver disease, after initiating insulin detemir. Furthermore, we will investigate the occurrence of hypoglycaemic events, change in the number of oral glucose lowering drugs used, and the adherence to insulin detemir among these patient groups. Insulin detemir has shown to be effective in controlling glycaemic levels in patients with T2DM. However, limited evidence is available describing the use in T2DM elderly patients and patients suffering from comorbidities such as cardiovascular/renal/hepatic impairment in a real-world setting. The study will use a retrospective cohort design, with first-time use of insulin detemir as index, to assess glycaemic control based on HbA1c prior to index and during a 12-month post-index follow-up period. Mixed model of repeated measures (MMRM) will be used to evaluate mean Hb1Ac levels from baseline to end of follow-up. The risk of hypoglycaemia will be evaluated based on number of events from index to 12-month follow-up and analysed using a negative binomial model. The adherence to insulin detemir will be described for the different patient groups by investigating at index to discontinuation insulin detemir usage using Cox proportional hazard regression.
Health Outcomes to be Measured: 
Glycaemic control; hypoglycaemia; oral glucose lowering drugs; adherence to treatment.

Dr Uffe Christian Braae - Chief Investigator - Novo Nordisk
Amra Ciric Alibegovic - Collaborator - Novo Nordisk
Dr Lise Lotte Nystrup Husemoen - Corresponding Applicant - Novo Nordisk
Professor Melanie Davies - Collaborator - University of Leicester
Renuka M - Collaborator - Novo Nordisk
Dr Sophie BIROT - Collaborator - Novo Nordisk