Comparing diabetes medications for heart health
Comparison of Type 2 Diabetes Pharmacotherapy Regimens Using Targeted Learning
This study is trying to see how different diabetes medications affect heart health in people with type 2 diabetes and if factors like age and when they start taking the medicine make a difference.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 6 sites (Oakland, California and 5 other locations) |
| Trial ID | NCT05073692 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of different glucose-lowering medications on heart health and other important outcomes for patients with type 2 diabetes. By analyzing real-world clinical data, the study will compare the cardiovascular outcomes of four classes of diabetes medications: SGLT2, GLP-1RA, DPP4, and SU. It will also investigate how the timing of medication initiation and patient characteristics such as age, sex, and baseline health status influence treatment benefits. Advanced causal inference methods and machine learning will be employed to ensure robust and precise estimates of medication effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-85 with a diagnosis of type 2 diabetes who have not previously been treated with the medications being compared.
Not a fit: Patients who are currently pregnant, have dementia, or have a short-term life expectancy due to prior cancer diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective diabetes medications for improving heart health in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown success in comparing diabetes medications, but this study employs novel methodologies to enhance the robustness of its findings.
Eligibility criteria
Show full inclusion / exclusion criteria
* Dispensing of either of the set of drugs being compared * No prior dispensing of any of the drugs compared * Evidence of Type 2 Diabetes Mellitus diagnosis * Age 18-85 * Not currently pregnant * No evidence of dementia or short-term life expectancy from prior cancer diagnoses * History of ≥2 years of continuous health plan membership * ≥1 A1c test in the past 18 months
Where this trial is running
Oakland, California and 5 other locations
- Romain S. Neugebauer — Oakland, California, United States (Recruiting)
- Kaiser Permanente Southern California — Pasadena, California, United States (Recruiting)
- Kaiser Permanente Hawaii — Honolulu, Hawaii, United States (Recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
- HealthPartners Institute — Bloomington, Minnesota, United States (Recruiting)
- Geisinger — Danville, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Romain S. Neugebauer, PhD — Kaiser Permanente
- Study coordinator: Romain S. Neugebauer, PhD
- Email: Romain.S.Neugebauer@kp.org
- Phone: (510) 910-2008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.