CompletedNot Applicable

Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses

United States48,262 participantsStarted 2011-05-01

Plain-language summary

This cohort study was initiated to predict the findings of CAROLINA trial in a real world setting using electronic claims data from insurance databases with results anticipated prior to the completion of CAROLINA.

Who can participate

Age range

40 Years – 85 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: * Patients with Type 2 diabetes who were new users of Linagliptin or new users of Glimepiride and: \- Had no more than 3 anti-diabetic drugs including index drug * AND at elevated risk of cardiovascular (CV) events according to specific criteria: * Previous vascular disease * Evidence of vascular-related end-organ damage * Age ⩾ 70 years * ⩾ 2 CV risk factors: * Treated hypertension * Smoking * Using any lipid lowering treatment * Age ≥ 40 and ≤ 85 years at treatment initiation Exclusion Criteria: * Patients with Type 1 Diabetes Mellitus * Previous exposure to dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, thiazolidinediones (TZDs), insulin or sodium glucose co-transporter-2 (SGLT-2s). * Exclude anti-diabetic background therapy if initiated in 2 months prior * Morbid obesity or treatment with anti-obesity drugs 3 months prior to treatment initiation * Severe hyperglycemia * Active liver disease or impaired hepatic function * Any previous bariatric surgery * Coronary artery re-vascularisation ≤ 6 weeks prior to treatment initiation * Prior hospitalization for congestive heart failure * Acute or chronic metabolic acidosis * Hereditary galactose intolerance * Alcohol or drug abuse within the 3 months prior to treatment initiation * Use of oral corticosteroids * Pregnant women * Patients with cancer * Acute coronary syndrome ≤ 6 weeks prior to treatment initiation * Stroke or Transient …

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

Composite Cardiovascular (CV) Outcome

Timeframe: From treatment initiation to end of follow-up, up to 53 months

Trial details

NCT IDNCT03648424

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06-01

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Who can participate

Age range

40 Years – 85 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.