Evaluating Second Line Diabetes Medications
BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes
This study looks at different second-line diabetes medications to see which ones work best for adults with Type 2 diabetes who are at moderate risk for heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550000 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 5 sites (Wilmington, Delaware and 4 other locations) |
| Trial ID | NCT05161429 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes electronic patient data to compare various second-line medications for Type 2 diabetes. It aims to identify which medications provide the best balance of risks and benefits for patients. By utilizing a large database from multiple healthcare institutions, the study focuses on adults aged 30 and older who have Type 2 diabetes and are at moderate risk for cardiovascular events. The research employs clinical trial emulation techniques to compare different classes of diabetes medications, including DPP4 inhibitors, GLP1 receptor agonists, basal insulin, SGLT2 inhibitors, and sulfonylureas.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 or older with Type 2 diabetes who have been on metformin and are at moderate risk for cardiovascular disease.
Not a fit: Patients with severe comorbidities or those who have not engaged with the healthcare system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective diabetes medications, improving treatment outcomes for patients.
How similar studies have performed: Other studies have successfully compared diabetes medications using similar observational approaches, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Individuals meeting the following criteria between January 1, 2015 and December 31, 2021: * Diabetes mellitus (DM) type II * HbA1c of 7-11% within the past year * Monotherapy with metformin for at least 3 months * No prior non-metformin outpatient diabetes therapy * Aged ≥30y * At "moderate" risk of ASCVD * Men aged ≥35y and women aged ≥45y with no history\* of stroke, myocardial infarction, revascularization, or heart failure hospitalization * Men aged 30-34 and women aged 30-44 with history\* of hypertension, hyperlipidemia, retinopathy, kidney disease or neuropathy * estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 within the past 3 years * Not pregnant at time 0 * No history\* of institutionalization with a diagnosis of dementia, metastatic cancer, end stage lung disease, end stage liver disease, pancreatitis, medullary thyroid cancer or severe UTIs * Engagement with the healthcare system: enrollment for at least 12 months and attendance of at least one outpatient encounter in the prior 12 months (\*) History will be derived from at least 12 months of EHR and claims prior to time zero and will use all available EHR and claims data between January 1, 2014 and time zero
Where this trial is running
Wilmington, Delaware and 4 other locations
- HealthCore, Inc. — Wilmington, Delaware, United States (Recruiting)
- Humana — Lexington, Kentucky, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Greater Plains Collaborative — Beachwood, Ohio, United States (Recruiting)
- Baylor Scott & White — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Turchin, MD, MS — Brigham and Women's Hospital
- Study coordinator: Emma Hegermiller, MS
- Email: emma@bestmed.org
- Phone: 617-732-5661
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.