- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01281605
Comparison of Two Titration Programs of Adding Insulin Detemir to OADs in Poorly Controlled Type 2 Diabetes
Comparison of Two Titration Programs of Adding Insulin Detemir to Oral Antidiabetic Drugs in Poorly Controlled Type 2 Diabetes Patients
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a 24-week, prospective, open-label, randomized, parallel-group study conducted in approximately 200 patients with type 2 diabetes in the Taiwan. The effectiveness of insulin detemir will be assessed at baseline and at 12 and 24 weeks after initiation of study prescription. The safety will be followed during the 24-week study period.
Inclusion criteria:
Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
After enrollment, eligible patients will be randomized in a 1:1 ratio to one of the following titration algorithms:
- Active titration algorithm: contact with investigator by telephone weekly.
- Usual titration algorithm: contact with investigator only at routine study visit.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Hsinchu, Taiwan, 30067
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital
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Taitung, Taiwan, 95054
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Patients must meet all of the following criteria:
- Men and women with type 2 diabetes.
- 20 years of age.
- Patients who have received stable doses of any OADs for at least 10 weeks prior to the screening visit.
- Patients with inadequate glycemic control (HbA1C >=7% and < 11%).
- Patients who are willing and able to cooperate with study and give signed informed consent.
Exclusion Criteria:
- Patients with type 1 diabetes.
- Renal dialysis patients.
- History of hypoglycemia unawareness.
- Patients who had received any insulin for more than 2 weeks or who have received insulin treatment within 4 weeks prior to screening visit.
- Patients who have received any investigational products (drug and device) within 4 weeks prior to screening visit.
- Patients hypersensitive with insulin detemir or its excipients.
- Patients who are currently pregnant/lactating,or who are preparing for pregnancy or lactation.
Plano de estudo
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 |
---|---|
Comparador Ativo: Active titration algorithm
titrate insulin dose by contacting with investigator by telephone weekly.
|
Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl).
Outros nomes:
|
Experimental: Usual titration algorithm
contact with investigator only at routine study visit.
|
All patients will be instructed to self-measure fasting capillary blood glucose.
The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values.
the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
To compare the change in HbA1c between two study groups at Week 24.
Prazo: 24 weeks
|
compare the change in HbA1c between two study groups after 24 weeks treatment.
|
24 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
To compare the change in HbA1C between two study groups at Week 12.
Prazo: 12 weeks
|
compare the change in HbA1C between two study groups after 12 of treatment.
|
12 weeks
|
To compare the proportion of patients achieving HbA1C <7% at Week 24
Prazo: 24 weeks
|
compare the proportion of patients achieving HbA1C <7% after 24 weeks treatment
|
24 weeks
|
To compare the changes in fasting plasma glucose (FPG) at Week 12 and 24.
Prazo: 24 weeks
|
compare the changes in fasting plasma glucose (FPG) after 12 and 24 treatment.
|
24 weeks
|
To compare the change in body weight at each visit
Prazo: 24 weeks
|
compare the change in body weight at each visit
|
24 weeks
|
To evaluate the incidence of adverse events.
Prazo: 24 weeks
|
evaluate the incidence of adverse events including hypoglycemia and any other adverse event.
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Sung-Chen Liu, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
- Investigador principal: Hui-Fang Chang, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu branch
- Investigador principal: Ke-Yan Wu, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Taitung branch
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10M MHIS112
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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