Time to treatment intensification and associated outcomes among patients with Type 2 diabetes mellitus in the UK

Date of ISAC Approval: 
04/09/2015
Lay Summary: 
Despite receiving treatment with metformin or sulfonylurea to manage Type 2 diabetes mellitus (T2DM), many patients fail to achieve the desired levels of glucose control. Poor glucose control is in turn associated with development of cardiovascular complications, further increasing the burden of the disease. Therefore, it is important to effectively manage high glucose levels, and to do so in a timely manner. The treatment guidelines recommend intensifying treatment with other oral and/or injectable diabetes medications among patients with poor glucose control. However, a recent study found that half of the patients with elevated glucose levels did not receive treatment intensification for over a year, suggesting that patients may be subject to prolonged periods of poor diabetes control. This study expands upon the prior research by assessing time to treatment intensification among those who do not achieve adequate glucose control with one diabetes therapy and assessing characteristics of patients stratified by time to treatment intensification. In addition, the study will evaluate the clinical and economic outcomes associated with different times of intensifying treatment.
Technical Summary: 
The proposed study will assess time to treatment intensification among T2DM patients not achieving adequate glycemic control with metformin or sulfonylurea alone (defined as first glycated haemoglobin [HbA1c] measurement 7% or less after at least 3 months of metformin or sulfonylurea use) using Kaplan-Meier survival analyses. In addition, the study aims to describe the characteristics of patients receiving early intensification, intermediate intensification, or late intensification after initial indication of monotherapy failure. The precise definitions for these stratifications will be determined based on the distribution of time to intensification observed within the study sample to reflect the treatment patterns in the UK population. Furthermore, time to attaining HbA1c levels <7% will be described for those with early versus intermediate and early versus late intensification using Kaplan-Meier survival analyses. Finally, for a subgroup of patients with linked hospital data available, the association between differential times to treatment intensification and incidence of microvascular and macrovascular complications will be assessed using Cox proportional hazards models.
Health Outcomes to be Measured: 
Time to treatment intensification Glycemic control Microvascular and macrovascular complications
Collaborators: 

Noam Kirson - Chief Investigator - Analysis Group, Inc.
Jayanti Mukherjee - Researcher - Bristol-Myers Squibb - USA (BMS)
Jennifer Kim - Researcher - Astra Zeneca Ltd - UK Headquarters
Professor Kamlesh Khunti - Researcher - University Of Leicester
Dr Katherine Tsai - Researcher - MedImmune
Nancy E Smith - Researcher - Bristol-Myers Squibb Pharmaceuticals Limited - UK (BMS)
Nebibe Varol - Researcher - Eli Lilly & Co Ltd - US Headquarters
Phillip R. Hunt - Researcher - Evidera, Inc
Sarah King - Researcher - Analysis Group, Inc.
Urvi Desai - Corresponding Applicant - Analysis Group, Inc.

Linkages: 
HES Admitted;HES Outpatient;ONS