Type 2 Diabetes Mellitus (T2DM) is an important public health issue. After lifestyle changes, patients are prescribed tablets to control the average blood glucose level (HbA1C). In general, patients are initially prescribed with single drug or therapy and only if the blood glucose levels do not decline over time, they are prescribed with multiple drugs or therapy.
We believe that patients with HbA1C level equal to or higher than 9% may benefit from starting on combination of different drugs rather than a single drug (i.e., monotherapy).
In this study we want to determine the number of patients who have a high HbA1C level (>9%) when they initiate medication, and of those how many patients initiate treatment with single drug and how many with a combination of drugs.
Additionally, we will follow the patients until 24 months after they initiate medication for T2DM, to compare the HbA1C levels achieved between those starting with multiple drugs to those starting with single drug. We will also look at how much time is taken for the patients to reach a lower HbA1c level (<7%) from the initial high HbA1c level.
The study analysis will include T2DM patients, aged 18 years and older, using the UK Clinical Practice Research Datalink (CPRD) database. The date of first prescription of an antidiabetic agent between January 2010-December 2015 will be the index date. Patients with continuous enrolment in the database one year prior to the index date, having an HbA1c lab value between 3 months before to 2 weeks after index date will be included. Patients will be excluded if they had type 1 diabetes mellitus, other forms of secondary diabetes, gestational diabetes mellitus, or had taken any antidiabetic drugs in the one-year baseline period.
Outcomes will be stratified by baseline HbA1c levels as well as by type of therapy (monotherapy and combination therapy). Patients with prescription for 2 or more different antidiabetic agents in the first month post index date (with at least 1 follow-up prescription for each agent) will be defined as combination therapy initiators.
We will evaluate the longitudinal change in HbA1c levels, at 12 months and 24 months from the baseline levels as well the time taken to achieve target HbA1c level of <7%. To evaluate the demographic and clinical differences between monotherapy initiators and combination therapy initiators, descriptive statistics and regression analysis will be used.
Baseline HbA1C
- Change in Hb1AC at 24 months (exploratory endpoint)
- BMI
- Therapy initiation (mono or combination)
- Baseline demographics (age, sex, race, region)
- T2D duration
- Change in Hb1AC at 12 months (exploratory endpoint)
- Diabetes-related comorbid conditions (e.g. microvascular, macrovascular, depression, etc)
- Charlson comorbidity index
Rogier Klok - Chief Investigator - Merck & Co., Inc.
Rogier Klok - Corresponding Applicant - Merck & Co., Inc.
Alex Z. Fu - Collaborator - CHEORS
Ankita Kumar - Collaborator - CHEORS
Kamlesh Khunti - Collaborator - University of Leicester
Swapnil Rajpathak - Collaborator - Merck & Co., Inc.