220 Participants Needed

Education Strategies for Safer Medication Use in Type 2 Diabetes

IN
AD
Overseen ByAmanda Davies, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
Must be taking: Sulfonylureas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial focuses on encouraging discussions about switching from sulfonylurea medications to newer alternatives. It does not specify if you must stop your current medications, but it aims to promote safer options.

Is dapagliflozin safe for humans?

Dapagliflozin, also known as Farxiga or Forxiga, is generally well tolerated in humans for the treatment of type 2 diabetes, with a low risk of low blood sugar (hypoglycemia) and common side effects like genital infections. It is not recommended for people with moderate or severe kidney problems.12345

How does this educational treatment for Type 2 diabetes differ from other treatments?

This treatment focuses on education strategies to improve medication adherence and self-management in Type 2 diabetes, which is different from traditional drug treatments. It aims to empower patients with knowledge to better manage their condition, potentially leading to improved glycemic control and reduced hospitalizations.678910

What data supports the effectiveness of the drug Farxiga (dapagliflozin) for safer medication use in type 2 diabetes?

Research shows that Farxiga (dapagliflozin) helps lower blood sugar levels and body weight in people with type 2 diabetes, and it is generally well tolerated. It also reduces the risk of kidney problems and heart-related issues in people with chronic kidney disease, even if they don't have diabetes.124511

Who Is on the Research Team?

IN

Ian Neeland, MD

Principal Investigator

University Hospital Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 45 and older with type 2 diabetes who have been seeing their primary care provider since at least 2021, are currently prescribed sulfonylurea medications, and can discuss medication changes with their doctor. It excludes those whose doctors advise against participation or who cannot give informed consent.

Inclusion Criteria

I am currently taking medication for diabetes.
Established care (≥2 visits) with UH primary care provider (PCP) since 2021
I am 45 years old or older.
See 1 more

Exclusion Criteria

I have Type 1 diabetes.
I am unable to understand and give consent for 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.)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are divided into an intervention group receiving a question-prompt sheet and a control group receiving a general brochure on diabetes medications. Primary care providers receive education about newer diabetes medications.

12 months
Up to 2 visits (in-person) for provider education

Follow-up

Participants are monitored for discussions about sulfonylureas and alternatives, discontinuation rates, and clinical outcomes such as Hb A1c, blood pressure, and lipid levels.

12 months
Surveys every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Prompt-sheet
  • Usual education
Trial Overview The study tests whether using a prompt-sheet to encourage patient-doctor discussions about the risks of sulfonylureas (a diabetes drug) leads to switching to safer alternatives. One group gets prompting questions; another gets general info. Doctors also learn about newer drugs.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Prompt-sheetExperimental Treatment1 Intervention
Group II: Usual educationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Ian J. Neeland, MD

Lead Sponsor

Trials
2
Recruited
280+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Published Research Related to This Trial

Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.
It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus.Davis, PN., Ndefo, UA., Oliver, A.[2021]
Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.
While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes.Maranghi, M., Carnovale, A., Durante, C., et al.[2021]
Dapagliflozin is an effective oral medication for managing type 2 diabetes by inhibiting glucose reabsorption in the kidneys, which helps lower blood sugar levels when diet and exercise alone are insufficient.
In addition to improving glycemic control, dapagliflozin may also aid in weight loss, making it a beneficial option for patients who struggle with weight gain from other diabetes treatments.
Dapagliflozin (Forxiga) for type 2 diabetes?[2021]

Citations

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]
Dapagliflozin (Forxiga) for type 2 diabetes? [2021]
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]
Dapagliflozin: a review of its use in patients with type 2 diabetes. [2022]
Dapagliflozin no longer licensed for type 1 diabetes. [2022]
Diabetes knowledge, medication adherence and glycemic control among patients with type 2 diabetes. [2022]
Effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes: a systematic review. [2020]
Diabetes education: looking through the kaleidoscope. [2013]
[Educational program to type 1 diabetes mellitus patients: basic topics]. [2022]
[Follow-up, therapeutic education, and pharmacologic treatments of patients with type 2 diabetes. Various critical views]. [2007]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security