Patient Characteristics Associated With Initiation Of Insulin Glargine Among Patients With Type 1 Or Type 2 Diabetes Mellitus In The United Kingdom

Date of Approval: 
2016-07-05 00:00:00
Lay Summary: 
This study is going to describe the number of people living in the UK treated with insulin. Insulin is used to treat people who have Type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) and Type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Then, we will look at what type of patient is put on insulin glargine. Insulin glargine is a long-acting, man-made version of human insulin. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar. The purpose of this study is to understand the number and type of patient treated with insulin. It is important to understand this so we can better understand and meet the medical needs of Type 1 and Type 2 diabetes patients on insulin.
Technical Summary: 
The objective of the study is to describe prescription patterns of insulin, the characteristics of patients initiating insulin glargine in real-world clinical practices and potential factors associated with the initiation of insulin glargine. Patients with insulin initiation between Jan 1st 2009 to Dec 31st 2013 will be included in this study. Patients will be required to have at least one year information before the initiation date (index date) and at least 90 days after index date. The primary outcome is to assess the prescription pattern of glargine and other types of insulin; the primary outcome is the first type of insulin drug prescribed during the index period. Logistic regressions will be conducted to identify the baseline characteristics associated with Glargine initiation versus the other insulin.
Health Outcomes to be Measured: 
To assess the prescription pattern of glargine and other types of insulin, the primary outcome is the first type of insulin drug prescribed during the index period. Specifically, the study will consider all types of insulin drugs: Rapid-acting: lispro (Humalog, Liprolog); aspart (NovoMix, NovoRapid); glulisin (Apidra) Short-acting: insulin human Intermediate-acting: NPH (isophane insulin) Long-acting: insulin glargine; insulin detemir; insulin degludec
Application Number: 
16_108
Collaborators: 

Romita Das - Chief Investigator - Merck Sharp & Dohme - UK
Jinan Liu - Corresponding Applicant - Janssen US
Berhanu Alemayehu - Collaborator - Merck & Co., Inc.
Gail Fernandes - Collaborator - Merck & Co., Inc.