ArticleDiabetes care2019
Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial: Cardiovascular Safety of Linagliptin Versus Glimepiride.
Article in Diabetes care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03648424 (Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses), which is not on this map. Cited by 47 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prediction of Findings From the Ongoing CAROLINA Trial Using Healthcare Database Analyses
Who cites it
47 citing papers in PubMed, 94 citations in OpenAlex.
- Using real-world data to predict findings of an ongoing phase IV trial: glycemic control of semaglutide versus standard of care.BMJ open diabetes research & care · 2025Trial
- Predicting Treatment Effects of a New-to-Market Drug in Clinical Practice Based on Phase III Randomized Trial Results.Clinical pharmacology and therapeutics · 2023Trial
- Bleeding Risk With Apixaban Versus Rivaroxaban: A Reference Trial Emulation Predicting the Results of COBRRA-VTE and COBRRA-AF Using US Health Care Claims.Circulation. Population health and outcomes · 2026Observational
- Article
- Illustrating an Adaptive Prespecification Framework for Observational Research: Target Trial Emulations Comparing Immunomodulator Treatments for COVID-19.Epidemiology (Cambridge, Mass.) · 2025Article
- Emulating randomized trials by observational database studies: the RCT-DUPLICATE initiative in COPD and asthma.American journal of epidemiology · 2025Article
- Population-Based Validation Results From the Drug Repurposing for Effective Alzheimer's Medicines (DREAM) Study.Clinical pharmacology and therapeutics · 2025Article
- Geospatial distribution of the adoption of dipeptidyl-peptidase-4 inhibitors for type 2 diabetes among Medicare beneficiaries.Spatial and spatio-temporal epidemiology · 2025Article
- Feasibility of using real-world data to emulate substance use disorder clinical trials: a cross-sectional study.BMC medical research methodology · 2024Article
- Comparison of glimepiride and linagliptin in the treatment of non-alcoholic hepatic disease with type 2 diabetes mellitus.Archives of medical science : AMS · 2024Article
- A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.Diabetes care · 2023Review
- Use of Real-World Data in Population Science to Improve the Prevention and Care of Diabetes-Related Outcomes.Diabetes care · 2023Review
- An Attempt to Replicate Randomized Trials of Diabetes Treatments Using a Japanese Administrative Claims and Health Checkup Database: A Feasibility Study.Drugs - real world outcomes · 2023Article
- Hydroxychloroquine lowers Alzheimer's disease and related dementias risk and rescues molecular phenotypes related to Alzheimer's disease.Molecular psychiatry · 2023Article
- HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.Pharmacoepidemiology and drug safety · 2023Article
- Occurrence of inflammatory bowel disease in patients with chronic inflammatory skin diseases: a cohort study: Classification: Epidemiology.The British journal of dermatology · 2022Article
- Comparative Effectiveness of Empagliflozin vs Liraglutide or Sitagliptin in Older Adults With Diverse Patient Characteristics.JAMA network open · 2022Article
- Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.Nature communications · 2022Article
- A Comparison of Individuals with Diabetes and EMPA-REG Trial Participants: Exploring Aspects of External Validity.Journal of general internal medicine · 2022Article
- Evolving channeling in prescribing SGLT-2 inhibitors as first-line treatment for type 2 diabetes.Pharmacoepidemiology and drug safety · 2022Article
Corrections and comments
- Comment on
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveUsing real-world data (RWD) from three U.S. claims data sets, we aim to predict the findings of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA) comparing linagliptin versus glimepiride in patients with type 2 diabetes (T2D) at increased cardiovascular risk by using a novel framework that requires passing prespecified validity checks before analyzing the primary outcome. RESEARCH DESIGN AND
methodsWithin Medicare and two commercial claims data sets (May 2011-September 2015), we identified a 1:1 propensity score-matched (PSM) cohort of T2D patients 40-85 years old at increased cardiovascular risk who initiated linagliptin or glimepiride by adapting eligibility criteria from CAROLINA. PSM was used to balance >120 confounders. Validity checks included the evaluation of expected power, covariate balance, and two control outcomes for which we expected a positive association and a null finding. We registered the protocol (NCT03648424, ClinicalTrials.gov) before evaluating the composite cardiovascular outcome based on CAROLINA's primary end point. Hazard ratios (HR) and 95% CIs were estimated in each data source and pooled with a fixed-effects meta-analysis.
resultsWe identified 24,131 PSM pairs of linagliptin and glimepiride initiators with sufficient power for noninferiority (>98%). Exposure groups achieved excellent covariate balance, including key laboratory results, and expected associations between glimepiride and hypoglycemia (HR 2.38 [95% CI 1.79-3.13]) and between linagliptin and end-stage renal disease (HR 1.08 [0.66-1.79]) were replicated. Linagliptin was associated with a 9% decreased risk in the composite cardiovascular outcome with a CI including the null (HR 0.91 [0.79-1.05]), in line with noninferiority.
conclusionsIn a nonrandomized RWD study, we found that linagliptin has noninferior risk of a composite cardiovascular outcome compared with glimepiride.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.