Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes
Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients
The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.
The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on
- Blood Glucose
- Insulin
- Intact proinsulin
- Asymmetric dimethylarginine (ADMA)
- Metal matrix proteasis (MMP-9)
- Oxidative status (per ox)
- Interleukin 18 (IL-18)
- Free fatty acids (FFA)
- Oxidised LDL (ox-LDL)
- Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)
- Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44).
Efficacy Variables Primary efficacy variablePostprandial time course of nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine, dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type 2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3 months Sample Size N = 15
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Alemanha, 55116
- Ikfe
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Type 2 Diabetes mellitus according to the ADA criteria
- HbA1c between 6.5 % and 9.9 %
- Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
- Age between 40 and 70 years
- BMI < 40
Exclusion Criteria:
- Type 1 Diabetes mellitus
- Pre-Treatment with insulin within the last 6 months prior to screening
- Treatment with glitazones within the last 6 months prior to screening
- Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
- Untreated hypertension stage II-III according to WHO criteria
- Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- Total Cholesterol > 300 mg/dl (anamnestically)
- Hypokalemia (K < 3.5 mmol /l)
- Major micro- or macrovascular complications as judged by the investigator
- Tobacco use within the last 12 months prior to screening
- Drugs with major impact on endothelial function like nitrates etc.
- History of drug or alcohol abuse within the last five years prior to screening
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women, > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- Pregnancy or breast feeding
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
One Day Treatment with Insulin Glulisine
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100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
Outros nomes:
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Comparador Ativo: 2
One day Treatment with Human insulin
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100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin
Prazo: 1 day
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1 day
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C
Prazo: 1 day
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas A Forst, Prof, MD, Institute for Clinical Research and Development
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- APIDR_L_01896
- EudraCT Number 2006-005127-42
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