PCORI has identified the need for large studies that look at real-life questions facing diverse patients with type 2 diabetes, their families, caregivers, clinicians, and healthcare systems.
What is the research about?
This study is designed to help patients with type 2 diabetes and their clinicians (1) identify which glucose-lowering medications have the most favorable effects on heart health and other patient-important outcomes; (2) inform the timing of medication initiation; and (3) identify whether medication benefits apply equally to all adults with type 2 diabetes, or are different based on age, sex, race/ethnicity, baseline heart health status, baseline renal function, or other factors.
Who can this research help?
Adults with type 2 diabetes and their families, caregivers, and clinicians can use the study results as they consider which types of diabetes treatments would best meet their personal needs and health goals.
What is the research team doing?
The researcher team is working with six large care delivery systems with 12 million patients, and over 600,000 patients with type 2 diabetes. The team will carefully gather and analyze data from 2014 to 2023 to compare the impact of four classes of diabetes medications on patients’ health, in areas such as occurrence of premature death, stroke, heart attacks, heart surgery, heart failure, kidney failure, amputations, serious hypoglycemia, weight gain, and other patient-important diabetes complications. The team will also examine whether the health impact of these four classes of medications varies by patients’ characteristics (e.g., age; sex; race/ethnicity; beginning level of glucose control; prior heart problems; prior kidney problems; prior problems with weight, low blood sugars, high blood sugars) at the time they start taking the medication. The researchers will recruit 12–18 patient, caregiver, clinician, and health plan stakeholders to join their team. These individuals will (1) help the study focus on topics that are important to patients, caregivers, and clinicians; (2) guide how data are analyzed; and (3) develop and refine strategies to effectively communicate study results to patients, families, caregivers, clinicians, and health plans.
The study involves collecting the minimum necessary amount of health information from medical records and from insurance databases at the six study sites. After removing patient names and other identifying information, the data from the six sites will be combined for analysis at one site. The study will be reviewed in advance, approved, and monitored by an Institutional Review Board. Data privacy, data security, and data use are governed by a required formal Data Use Agreement among the six study sites.
Research methods at a glance
- Design: Cohort study from January 1, 2014, through May 30, 2023
- Population: Patients at one of the six study sites with type 2 diabetes who are aged 18–85 years
- Comparators: The study will compare the effects of sulfonylureas, DPP4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists on outcomes of interest and the timing of their initiation.
- Primary Outcome: Time to first occurrence of (1) cardiovascular death, (2) nonfatal stroke, or (3) nonfatal heart attack
- Secondary Outcomes: Time from starting a medication of interest to death from any cause, cardiovascular death, fatal or nonfatal heart attack or stroke, heart failure hospitalization, heart bypass surgery or stent placement, progression of kidney disease, end-stage kidney disease, severely high or low glucose, weight gain, nontraumatic lower limb amputation, or other outcomes deemed by patient stakeholders to be of interest
- Timeframe: The three-year period for conducting the study will begin on July 1, 2021, and end on May 30, 2024. Data included in the analysis are taken from medical records and insurance databases from January 1, 2014, to May 30, 2023.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.