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Comparative effectiveness of metformin for type 2 diabetes with chronic kidney disease
Investigator (PI): Mushlin, Alvin
Performing Organization (PO): (Current): Cornell University, Weill Cornell Medical College, Department of Population Health Sciences / (646) 962-9401
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/CER-2017C3-9230
Funding: Total Award Amount: $2,453,705
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. 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 (1) blood sugar levels; (2) HbA1c, which measures average blood sugar levels over the past three months; (3) body mass index, or BMI, which estimates body fat based on height and weight; (4) hospital visits for buildup of acid in the bloodstream, high blood sugar, heart attack, stroke, and heart failure; and (5) 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. Design: The study design is observational: cohort study. Population: The study population is 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 are metformin, sulfonylurea, DPP-4 inhibitor, SGLT2 inhibitor, and GLP1 receptor agonist. Outcomes: Outcomes are (a) primary: severe hypoglycemia defined as emergency room, observation, or inpatient visits where hypoglycemia is the primary diagnosis; change in HbA1c after 3-9 months; and heterogeneity of treatment effect; and (b) 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, and change in eGFR. The timeframe is up to 25-month follow-up for primary outcomes.
Abstract Archived: Most patients with type 2 diabetes are treated first with a medicine called metformin, which helps the body to better use the natural insulin it produces. However, many doctors are reluctant to use metformin to treat patients who have kidney disease, which is a very common problem for people how have diabetes. This is because experiences fifty years ago with drugs similar to metformin showed that some of them were dangerous in kidney disease. Since then, it has become clear that metformin is safe in patients with very mild kidney disease, but we still do not know enough about metformin's safety in people with more serious kidney disease. We will use a very large collection of medical records and laboratory results from patients with diabetes and kidney disease who are treated with metformin, compared to the patients who are treated with commonly used alternative drugs. We will analyze the blood sugar results and the number of people with side effects including very low blood sugar. Our goal will be to determine which patients are better off taking metformin than other drugs, and whether metformin should be used even in patients with serious kidney disease. The results of this project will help to inform patients with diabetes and their physicians about what medication to use to achieve the best outcomes. In this entire project, from the beginning to end, patients will be partners in the research. The patient partners will advise about what research questions are most important and what kind of analysis of the data to do. They will also help to interpret the results. After the findings are known, patient partners will be part of the team that explains the study, its findings, and how diabetes care can be improved in the future.

MeSH Terms:
  • Blood Glucose /analysis
  • Chronic Kidney Failure /complications
  • /*therapy
  • Comorbidity
  • Comparative Effectiveness Research
  • Data Collection
  • Health Services Research
  • Humans
  • Medical Records
  • Metformin /*therapeutic use
  • NIDDM /complications
  • /*drug therapy
  • Outcome Assessment, Health Care
  • Patient Participation
Country: United States
State: New York
Zip Code: 10065
UI: 20193212
CTgovId: NCT03921242
Project Status: Ongoing
Record History: ('2020: Archived abstract to Abstract Archived 1 field and added new abstract. Alternate Title: Comparing medicines for treating type 2 diabetes among patients with chronic kidney disease',)