- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02993614
Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors (CVD-REAL)
Characteristics and Cardiovascular and Mortality Outcomes in Patients With Type 2 Diabetes Mellitus Initiating Treatment With Sodium-glucose Co-transporter-2 Inhibitors (SGLT-2i) and Other Glucose Lowering Drugs
Visão geral do estudo
Status
Condições
Descrição detalhada
Type 2 diabetes mellitus remains a major risk factor for cardiovascular disease with an estimated 425 million adults worldwide having diabetes in 2017, with type 2 diabetes mellitus accounting for about 90% of the cases. Recent evidence indicates that certain glucose-lowering therapies are associated with reduction in cardiovascular outcomes. There is, therefore, an urgent need to improve the understanding of the impact of newer classes of glucose-lowering therapies, such as dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose co-transporter-2 (SGLT-2) inhibitors on cardiovascular outcomes in clinical practice.
CVD-REAL is a comparative effectiveness study that aims to compare new users of SGLT-2 inhibitors with new users of other glucose-lowering drugs with regard to the risk of all-cause mortality and clinically relevant CV outcomes (including stroke, myocardial infarction, and hospitalization for heart failure) respectively. The study is based on data from 12 countries across four major world regions.
The study is conducted using data from claims, medical records and national health registries from twelve countries combined in two waves. CVD-REAL 1 includes Germany, Denmark, Norway, Sweden, United Kingdom (UK) and United States of America (USA). CVD-REAL 2 comprises Australia, Canada, Israel, Japan, Singapore and South Korea. The study will collect data from approximately 4 million patients from the time they start treatment with a SGLT-2 inhibitor or another glucose-lowering drug (index date) to the end of the follow-up period.
The Study Population will consist of new users of SGLT-2i and other glucose lowering drugs respectively. These will be compared with all-cause mortality, hospitalization for heart failure, myocardial infarction and stroke during the follow-up period. In addition certain other cardiovascular and renal outcomes will be assessed descriptively in the two groups respectively.
The study period will range from launch of the first SGLT-2i in each of the countries and end at latest available data in each data source.
All-cause mortality and the incidence of cardiovascular events will be compared between new users of SGLT-2 inhibitors and the comparator arm using a hazard ratio (relative risk) and corresponding 95% confidence interval. The analysis will be performed using the Cox proportional hazards model or some other appropriate method.
Matching by propensity scores will be used to balance the potential confounding covariates between the SGLT-2i group and the reference group to ensure that the two groups are as similar as possible at baseline.To achieve sufficient power, a meta-analysis will be applied to integrate the point estimates from each of the individual database analyses and calculate an overall weighted estimate and corresponding 95% CI.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
D1690r00015
-
Ulm, D1690r00015, Alemanha
- Research Site
-
-
-
-
D1690r00015
-
Melbourne, D1690r00015, Austrália
- Research Site
-
-
-
-
D1690r00015
-
Mississauga, D1690r00015, Canadá
- Research Site
-
-
-
-
D1690r00015
-
Singapore, D1690r00015, Cingapura
- Research Site
-
-
-
-
D1690r00015
-
Gentofte, D1690r00015, Dinamarca
- Research Site
-
-
-
-
D1690r00015
-
Madrid, D1690r00015, Espanha
- Research Site
-
-
-
-
Delaware
-
Wilmington, Delaware, Estados Unidos, 19850
- Research Site
-
-
-
-
D1690r00015
-
Espoo, D1690r00015, Finlândia
- Research Site
-
-
-
-
D1690r00015
-
Raanana, D1690r00015, Israel
- Research Site
-
-
-
-
D1690r00015
-
Rome, D1690r00015, Itália
- Research Site
-
-
-
-
D1690r00015
-
Tokyo, D1690r00015, Japão
- Research Site
-
-
-
-
D1690r00015
-
Oslo, D1690r00015, Noruega
- Research Site
-
-
-
-
D1690r00015
-
Porto, D1690r00015, Portugal
- Research Site
-
-
-
-
D1690r00015
-
Luton, D1690r00015, Reino Unido
- Research Site
-
-
-
-
D1690r00015
-
Seoul, D1690r00015, Republica da Coréia
- Research Site
-
-
-
-
D1690r00015
-
Sodertalje, D1690r00015, Suécia
- Research Site
-
-
-
-
D1690r00015
-
Taipei, D1690r00015, Taiwan
- Research Site
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- New user receiving or dispensed prescription of SGLT-2i medication or other glucose lowering drug, oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups
- T2DM diagnosis on or prior to the index date
- ≥ 18 years old at index date
- > 1 year data history in the database prior to the index date
Exclusion Criteria:
- Patients with a T1DM diagnosis
- Patients with gestational diabetes within 1 year before index date
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
CVD REAL1 Incidence of hospitalization for heart failure. / CVD REAL 2 All-cause mortality
Prazo: From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
|
Heart failure events obtained from general practice or hospital records, electronic health records or national health registers; All-cause mortality obtained from linkeage to death national registers
|
From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
CVD REAL1 All-cause mortality; CVD REAL 2: Hospitalization for heart failure (HHF), stroke, myocardial infarction (MI) and including composite endpoints
Prazo: From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
|
Events obtained from general practice or hospital records, electronic health records and national health registers.
All cause mortality obtained from linkeage to death national registers
|
From index date up to latest available data of first prescription of an SGLT-2i or a new oGLD in each of the countries ranging from Sep 11 (UK) until Apr 15 (IL) until the last date of data collection or outcome ranging from Sep 15 (US) to Nov 17 (SG)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Khunti K, Kosiborod M, Kim DJ, Kohsaka S, Lam CSP, Goh SY, Chiang CE, Shaw JE, Cavender MA, Tangri N, Franch-Nadal J, Holl RW, Jorgensen ME, Norhammar A, Eriksson JG, Zaccardi F, Karasik A, Magliano DJ, Thuresson M, Chen H, Wittbrodt E, Bodegard J, Surmont F, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular outcomes with sodium-glucose cotransporter-2 inhibitors vs other glucose-lowering drugs in 13 countries across three continents: analysis of CVD-REAL data. Cardiovasc Diabetol. 2021 Jul 31;20(1):159. doi: 10.1186/s12933-021-01345-z.
- Nicolucci A, Candido R, Cucinotta D, Graziano G, Rocca A, Rossi MC, Tuccinardi F, Manicardi V. Generalizability of Cardiovascular Safety Trials on SGLT2 Inhibitors to the Real World: Implications for Clinical Practice. Adv Ther. 2019 Oct;36(10):2895-2909. doi: 10.1007/s12325-019-01043-z. Epub 2019 Aug 13.
- Cavender MA, Norhammar A, Birkeland KI, Jorgensen ME, Wilding JP, Khunti K, Fu AZ, Bodegard J, Blak BT, Wittbrodt E, Thuresson M, Fenici P, Hammar N, Kosiborod M; CVD-REAL Investigators and Study Group. SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL. J Am Coll Cardiol. 2018 Jun 5;71(22):2497-2506. doi: 10.1016/j.jacc.2018.01.085.
- Kosiborod M, Lam CSP, Kohsaka S, Kim DJ, Karasik A, Shaw J, Tangri N, Goh SY, Thuresson M, Chen H, Surmont F, Hammar N, Fenici P; CVD-REAL Investigators and Study Group. Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study. J Am Coll Cardiol. 2018 Jun 12;71(23):2628-2639. doi: 10.1016/j.jacc.2018.03.009. Epub 2018 Mar 11.
- Kosiborod M, Cavender MA, Fu AZ, Wilding JP, Khunti K, Holl RW, Norhammar A, Birkeland KI, Jorgensen ME, Thuresson M, Arya N, Bodegard J, Hammar N, Fenici P; CVD-REAL Investigators and Study Group*. Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors). Circulation. 2017 Jul 18;136(3):249-259. doi: 10.1161/CIRCULATIONAHA.117.029190. Epub 2017 May 18.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D1690R00015
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .