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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from University Hospitals Cleveland Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Sponsor changed: Ian J. Neeland, MD to University Hospitals Cleveland Medical Center
    v7
  2. Minor Site contact updatedv6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Lead sponsor: University Hospitals Cleveland Medical Center to Ian J. Neeland, MD
    • Secondary endpoints revised (9)
    • Study description expanded, about 2 words
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05933174
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: American Heart Association
Conditions
(from sponsor)
Type2diabetes
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov