- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01600950
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
3 de outubro de 2014 atualizado por: Eli Lilly and Company
Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes.
Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time.
There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy.
The duration of this study can be up to 9.5 weeks.
The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
20
Estágio
- Fase 1
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
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Neuss, Alemanha, 41460
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
18 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- have had a duration of diabetes ≥1 year
- have hemoglobin A1c ≤10.0%
- have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- have a body mass index ≤29 kilograms per square meter (kg/m²)
- have venous access sufficient to allow blood sampling and cannulation for clamp procedures
Exclusion Criteria:
- are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- have a history of proliferative retinopathy
- have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- have an electrocardiogram (ECG) reading considered outside the normal limits
- have an abnormal blood pressure
- have abnormal clinical laboratory tests
- have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
- show evidence of significant active neuropsychiatric disease
- regular use of known drugs of abuse and/or show positive findings on drug screening
- show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
- had more than 1 episode of severe hypoglycemia within 6 months prior to study
- undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
- had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
- are receiving systemic glucocorticoid therapy
- have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
- show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
- smoke more than 10 cigarettes (or equivalent other tobacco products) per day
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 cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: LY2963016
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
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Single 0.3 U/kg dose administered subcutaneously
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Comparador Ativo: Lantus
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
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Single 0.3 U/kg dose administered subcutaneously
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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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Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion.
Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Maximum Glucose Infusion Rate (Rmax)
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Data presented are the maximum infusion rates, adjusted by body weight.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Total Glucose Infused (Gtot)
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Data presented are the total glucose infused, adjusted by body weight.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Time of Maximum Glucose Infusion Rate (tRmax)
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
Prazo: Periods 1 and 2: Baseline up to 42 hours postdose
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AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
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Periods 1 and 2: Baseline up to 42 hours postdose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 maio de 2012
Conclusão Primária (Real)
1 de julho de 2012
Conclusão do estudo (Real)
1 de julho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
15 de maio de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de maio de 2012
Primeira postagem (Estimativa)
17 de maio de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
7 de outubro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de outubro de 2014
Última verificação
1 de outubro de 2014
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13831
- I4L-MC-ABEE (Outro identificador: Eli Lilly and Company)
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 .
Ensaios clínicos em LY2963016
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Eli Lilly and CompanyBoehringer IngelheimConcluídoDiabetes Mellitus, Tipo 1Japão, Estados Unidos, Grécia, Bélgica, Polônia, Alemanha, Hungria, México, Romênia
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Eli Lilly and CompanyConcluídoDiabetes MellitusCingapura
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Eli Lilly and CompanyConcluídoDiabetes MellitusÁfrica do Sul