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Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors (ENERGY)

7 de maio de 2012 atualizado por: Novartis Pharmaceuticals

A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients

This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

160

Estágio

  • Fase 4

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.

Locais de estudo

  • China
      • BeiJing, China, 100020
        • People's Liberation Army. The Military General Hospital of BeiJing
      • BeiJing, China, 100034
        • Peiking University First Hospital
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Guangzhou, China, 510080
        • The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
      • Guangzhou, China, 510120
        • The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
      • Guangzhou, China, 510515
        • Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Newly diagnosed type 2 diabetes mellitus patients
  • HbA1c > 6.5 and < 9.0%
  • Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control

Exclusion Criteria:

  • History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
  • Liver disease
  • Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.

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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
Medicamento: Nateglinide 120 mg
Nateglinide 120 mg was supplied as tablets.
Outros nomes:
  • Starlix
Comparador Ativo: Acarbose 50 mg
Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
Medicamento: Acarbose 50 mg
Acarbose 50 mg was supplied as tablets.
Outros nomes:
  • Glucobay

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Baseline to the end of the study (Week 4)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Baseline to the end of the study (Week 4)
Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Baseline to the end of the study (Week 4)
Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Total cholesterol was assessed at each study site using the same method and same reference value.
Baseline to the end of the study (Week 4)
Change From Baseline in Triglycerides at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Triglycerides were assessed at each study site using the same method and same reference value.
Baseline to the end of the study (Week 4)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. LDL-C was assessed at each study site using the same method and same reference value.
Baseline to the end of the study (Week 4)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.
Baseline to the end of the study (Week 4)
Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. FFA was assayed at a central laboratory.
Baseline to the end of the study (Week 4)
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.
Baseline to the end of the study (Week 4)
Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
Prazo: Baseline to the end of the study (Week 4)
Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. GSA was assayed at a central laboratory.
Baseline to the end of the study (Week 4)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Publicações e links úteis

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Publicações Gerais

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

1 de julho de 2009

Conclusão Primária (Real)

1 de junho de 2010

Conclusão do estudo (Real)

1 de junho de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

25 de junho de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2009

Primeira postagem (Estimativa)

26 de junho de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de maio de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2012

Última verificação

1 de maio de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CDJN608ACN06

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 .

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