A Retrospective Real-World Cohort Study (SCALA-TK-CM)
19 de agosto de 2026 atualizado por: Novo Nordisk A/S
SCALA-TK-CM: Semaglutide and CArdiometabolic Real-Life Atlas - TürKiye CardioMetabolic Epidemiology Study: A Retrospective Real-World Cohort Study
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions.
Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
100000
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Novo Nordisk
- Número de telefone: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Locais de estudo
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Copenhagen, Dinamarca
- Novo Nordisk Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
SCALA cohort
Descrição
Inclusion Criteria:
- Participants aged above or equal to 12 years at index date.
- Participants with international classification of diseases (ICD-10) coded diagnosis or secondary criteria for either diabetes (type 2 diabetes, pre-diabetes), overweight, obesity, metabolic dysfunction-associated steatotic liver disease (or non-alcoholic fatty liver disease), cardiovascular disease (arterial hypertension, ischemic heart disease, myocardial infarction, heart failure, cerebrovascular disease (including stroke and transient ischemic attack), atherosclerosis, atrial fibrillation), chronic kidney disease, dyslipidemia.
- At least one healthcare encounter within 12 months prior to index date (pre-index) to ensure availability of baseline data.
Exclusion Criteria:
- None.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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SCALA cohort
Participants from Acibadem hospital network in Türkiye with index date followed by at least one year of follow-up and the data extraction period spanning from 1 January 2022 to 31 December 2025.
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Nenhum tratamento dado
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Index and yearly prevalence of major cardiometabolic diseases (percentage)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
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Measured in percentage
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
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Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
|
Measured as binary (yes/no)
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year
|
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Overlap of major cardiometabolic diseases (percentage)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date.
Measured as percentage
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Overlap of major cardiometabolic diseases: binary (yes/no)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date.
Measured as binary (yes/no)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Age distribution
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in years
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Age distribution: Number of participants
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured as number of participants
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Gender distribution
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Defined as male or female.
Measured in percentage
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Gender distribution: binary (yes/no)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Defined as count of male or female.
Measured as binary (male/female)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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BMI distribution
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured as kilogram (kg)/m^2
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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BMI distribution: number of participants
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Medical history of interest: percentage of events
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in percentage of events
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Smoking status: percentage of participants
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Defined by the next categories at index date non-smoker, formal smoker, occasional smoker or current smoker.
Measured in percentage of participants
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Systolic and diastolic blood pressure (BP)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in millimeters of mercury (mmHg)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in milligram (mg) /Liter (L)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of CRP .
Measured as binary (under and above 2 mg/L)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of ferritin
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in nanogram (ng)/mL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of transferrin
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/ deciliter (dL)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of serum creatinine
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of estimated glomerular filtration rate (eGFR)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mL/min/1.73m^2 in categories (under 30 / 30-44 / 45-59 / above or equal to 60 mL/min/1.73m^2)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of creatinine clearence (CrCl)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mL/ minute (min)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of serum albumin levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in grams (g)/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of albuminuria
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Defined as UACR (urine albumin-to-creatinine ratio) under 30 (A1), above or equal to 30 (A2), or above or equal to 300 mg/g (A3).
Measured in mg/g in categories (A1 / A2 / A3)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of albumin-tocreatinine ratio (ACR)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/g
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of platelets
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of neutrophils
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of lymphocytes
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of monocytes
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of fasting glucose
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of hemoglobin (Hb)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in g/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of hemoglobin A1c (HbA1c)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in percentage of total Hb
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
|
Laboratory assessment of triglycerides
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of total cholesterol
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of lipoprotein A (LpA)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of alanine transaminase (ALT)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in unit (U) /L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of aspartate transaminase (AST)
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in U/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of FIB-4 score
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
FIB-4 liver fibrosis score, with previously validated cut-off points to rule in and out the risk of advanced liver fibrosis.
FIB-4 score indicating low to high risk ranges from 0.1 (low risk) to 20 (highest risk), where the higher score indicates a higher risk or greater severity of advanced liver fibrosis.
Measured categorically as score on the scale (under 1.45, 1.45-2.67,
and above 2.67).
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
|
Laboratory assessment of thyroid-stimulating hormone (TSH) levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in milli-unit (mU)/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of follicle-stimulating hormone (FSH) levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in U/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of luteinizing hormone (LH) levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in U/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of progesterone levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in ng/mL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of estrogen levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in picograms (pg)/mL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of testosterone levels
Prazo: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
Measured in ng/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
20 de agosto de 2026
Conclusão Primária (Estimado)
2 de novembro de 2026
Conclusão do estudo (Estimado)
2 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
19 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças do Sistema Endócrino
- Processos Patológicos
- Distúrbios Nutricionais
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doença crônica
- Atributos da doença
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Insuficiência renal
- Excesso de peso
- Distúrbios do metabolismo lipídico
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade
- Diabetes Mellitus, Tipo 2
- Doenças cardiovasculares
- Insuficiência Renal Crônica
- Dislipidemias
- Estado pré-diabético
Outros números de identificação do estudo
- DAS-9012
- U1111-1341-4025 (Outro identificador: World Health Organization (WHO))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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