Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Dia… (NCT05220917) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
United States781,430 participantsStarted 2021-08-01
Plain-language summary
To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons in patients with type 2 diabetes (T2D).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years for Optum Cliniformatics, IBM Marketscan, CPRD, and VHA, and ≥ 65 years for Medicare FFS at cohort entry
* At least 12 months of continuous health plan enrollment (only claims) or registration with a general practitioner (CPRD) before and including cohort entry
* Diagnosis of T2D within 12 months before (or ever before in CPRD) and including cohort entry
* Low or moderate cardiovascular (CV) risk (≤3% risk of CV events/year) at cohort entry \*
* Metformin maintenance therapy, defined as 2 fills (or prescriptions in CPRD) of metformin monotherapy recorded within 6 months before and including cohort entry
Exclusion Criteria:
* Missing age or gender information
* Nursing care admission within 12 months before and including cohort entry (criteria ignored in CPRD)
* Diagnosis of type 1 diabetes within 12 months before and including cohort entry
* Diagnosis of secondary or gestational diabetes within 12 months before and including cohort entry
* Any insulin fill or prescription within 12 months before and including cohort entry
* Diagnosis of end stage renal disease (stage ≥ 5) within 12 months before and including cohort entry
* Diagnosis of acute or chronic pancreatitis within 12 months before and including cohort entry
* Diagnosis of cirrhosis or acute hepatitis within 12 months before and including cohort entry
* Diagnosis of MEN-2 within 12 months before and including cohort entry
* Recorded solid organ transplant code within 12 months b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MACE
Timeframe: through study completion, an average of 1 year
2
Modified MACE
Timeframe: through study completion, an average of 1 year
3
Hospitalization for Heart Failure (HHF) Hospitalization for Heart Failure (HHF)
Timeframe: through study completion, an average of 1 year