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NCT05933174Recruiting

Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

Sulfonylurea medications are unsafe for older patients with diabetes. They are associated not only with hypoglycemia, but also with falls and increased cardiovascular risk. Yet they continue to be prescribed frequently. Indeed, older adults with type 2 diabetes, who are especially prone to adverse effects, are more likely to be prescribed sulfonylureas than younger patients. This is unfortunate since over the past several years, newer, safer, and more effective classes of medications (GLP-1 agonists and SGLT2-inhibitors) have emerged. The investigators acknowledge that sulfonylureas are inexpensive and that their low cost is a driver of continued use. However, the investigators believe patients and providers should have discussions about the risks of sulfonylureas and safer and more effective alternatives, to make diabetes care safer overall in ambulatory settings. Our research is designed to promote such discussions. The investigators will first identify patients taking sulfonylureas regularly. Next, using recommendations from AHRQ and the Canadian Deprescribing Network, the investigators will empower patients to discuss their medications with their providers through a simple question prompt sheet. Patients will be divided into an intervention group which receives explicit prompting questions, and a control group that receives a general brochure on diabetes medications. Health care providers will receive education about newer diabetes medications through case-based discussions and academic detailing. Finally the investigators will measure key outcomes including the proportion of patients who have discussions about sulfonylureas and alternatives, rates of discontinuation, and measures of control of diabetes and associated cardiovascular risks. The investigators will also evaluate the experiences of patients and providers qualitatively through brief, semi-structured interviews. Should our multi-faceted, patient-oriented intervention prove effective in promoting discussions of sulfonylureas and alternatives, and also discontinuation of sulfonylureas and switching to newer alternatives, the investigators will incorporate our prompting questions into routine care for patients taking sulfonylureas. Our intervention can be easily disseminated to other settings and therefore has considerable potential to improve safety among patients with type 2 diabetes nationwide.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
220 (estimated)
First submitted
27 Jun 2023
Start date
1 Oct 2023
Primary completion date
30 Jun 2027
Lead sponsor
University Hospitals Cleveland Medical Center
NCT number
NCT05933174

What you commit to

  • Study type: Interventional
  • Planned participants: 220
  • From 1 Oct 2023 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)

Other illness

  • Type 1 diabetes

Other

  • Patient unable or unwilling to have conversation with their PCP regarding SU
  • Unable to provide informed consent

Who the study is looking for

  • Age ≥ 45 years
  • Type 2 diabetes (diagnosed on or before 12/31/2021)
  • Current/active prescription for one or more SU medications
  • Established care (≥2 visits) with UH primary care provider (PCP) since 2021

Age in the registry: 45 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.