Type 2 diabetes mellitus (T2DM) is a metabolic disorder that leads to elevated blood glucose (BG) levels, which over time can result in complications. Treatment with insulin is required to control BG levels in most patients as the disease progresses. Insulin treatment minimises the risk of long-term complications, but is associated with increased risk of low BG levels and weight gain. Biphasic Insulin Aspart 30/70 (BIAsp 30) is safe insulin, effective in reducing BG levels in T2DM patients. However, there is limited evidence as to the effect of BIAsp 30 in specific T2DM populations of different ethnic descent. We propose to study BG control in T2DM first-time users of BIAsp 30 living in England, but belonging to different ethnic groups e.g. Chinese, Indian, Pakistani. By using routinely collected health information, the change in BG levels can be investigated in patients prescribed BIAsp 30 for the first time by their general practitioner. The study will provide insights to the knowledge gap about the effect of BIAsp 30 on controlling BG levels and the occurrence of low BG levels in T2DM patients of different ethnic descent in a real-world setting.
This study aims to investigate glycaemic control and clinical characteristics in insulin-naïve T2DM patient groups of different ethnic descent e.g. Caucasian, Chinese, Indian, Pakistani living in England, when initiating BIAsp 30. Furthermore, we will investigate the occurrence of hypoglycaemic events and change in weight after initiation of insulin treatment. BIAsp 30 is effective in controlling glycaemic levels in patients with T2DM, however, limited evidence is available describing the use in patients of various ethnic descent in a real-world setting. The study will use a retrospective cohort design, with first time use of BIAsp 30 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. Identical methodology will be used to examine change in mean weight. The risk of hypoglycaemia will be evaluated based on the number of hypoglycaemia events from 12 months prior index to index compared to the number of events following from index to 12 months post index and analysed using a negative binomial regression model with a log-transformed offset.
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
Melanie Davies - Collaborator - University of Leicester
Renuka M - Collaborator - Novo Nordisk A/S
Rikke Baastrup Nordsborg - Collaborator - Novo Nordisk A/S