Project Summary
What is the research about?
Type 2 diabetes is a long-term illness that causes blood sugar levels to rise. Diabetes can be hard to manage and can lead to many health problems, such as kidney disease. Many patients with diabetes take a medicine called metformin. Metformin helps the body better use the insulin it produces. But research studies done 50 years ago showed that medicines related to metformin were harmful for patients with kidney disease. As a result, many doctors don’t use metformin to treat patients with kidney disease. More recently, studies have shown metformin to be safe for patients with mild to moderate kidney disease. But researchers still don’t know if metformin is safe for people with serious kidney disease.
In this study, the research team is comparing metformin with other commonly used medicines to see how well each treats type 2 diabetes among patients with chronic kidney disease. The team is also looking to see if the effect of the medicines varies for different groups of people based on factors such as age and race.
Who can this research help?
Results may help patients with type 2 diabetes and chronic kidney disease and their doctors when considering how to treat type 2 diabetes.
What is the research team doing?
The research team is looking at health records and lab results from patients with type 2 diabetes and kidney disease. The team is comparing patients taking metformin and patients treated with other commonly used medicines to see how well each treatment reduces
- Blood sugar levels
- HbA1c, which measures average blood sugar levels over the past three months
- Body mass index, or BMI, which estimates body fat based on height and weight
- Hospital visits for buildup of acid in the bloodstream, high blood sugar, heart attack, stroke, and heart failure
- Blood sugar and HbA1c for different groups of patients by age; sex; BMI; race; history of kidney disease, liver disease, and heart failure; renal function; and metformin dose
Patients are providing input on this study from start to finish, including helping to choose research questions and interpret results.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Observational: cohort study |
| Population | 16,000 adults ages 18 and older with type 2 diabetes mellitus and chronic kidney disease who are starting metformin or one of the comparator drugs and have at least one prescription for metformin, sulfonylurea, or a DPP-4 inhibitor; at least 6 months preceding that prescription in which none of those drugs were used; and an eGFR within 1 month prior to the index date of <60 mL/min |
| Interventions/ Comparators |
|
| Outcomes |
Primary: severe hypoglycemia defined as emergency room, observation, or inpatient visits where hypoglycemia is the primary diagnosis; change in HbA1c after 3–9 months; heterogeneity of treatment effect Secondary: acidosis, hospitalization for hyperglycemia, acute myocardial infarction, stroke, hospitalization or emergency room visits for heart failure, change in HbA1c after 12–24 months, change in BMI, change in eGFR |
| Up to 25-month follow-up for primary outcomes |
COVID-19-Related Study
Summary
Patients with type 2 diabetes and other related health problems, such as obesity or kidney disease, may have a high risk of severe COVID-19. Severe COVID-19 can lead to a hospital stay, breathing support by machine, and even death. Patients and their health providers want to know how to manage diabetes to reduce these risks.
With this enhancement, the research team will look at whether people with high blood sugar have a higher risk of a hospital stay. The team will also compare rates of COVID-19 hospital stays for people who take different diabetes medicines. Results will help patients and their providers manage and treat diabetes during the pandemic.
Enhancement Award Amount: $472,323
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Project Information
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Study Registration Information
^James Flory, MD, was the original principal investigator on this project.