Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0% as the treatment goal.
Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.
The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.
Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.
The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Capital Region
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Gentofte, Capital Region, Dinamarca, 2820
- Steno Diabetes Center Copenhagen
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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:
- T1D according to WHO criteria with duration of ≥1 year
- Age ≥18 years
- BMI >22.0 kg/m2
- HbA1c >7.5% and <10.0% at visit 0 (screening)
- Able to count carbohydrates
Exclusion Criteria:
- Insulin pump treatment
- Hypoglycaemia unawareness (inability to register low blood glucose)
- Diabetic gastroparesis
- Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- History of acute and/or chronic pancreatitis
- Subjects with personal or family history of medullary carcinoma or MEN syndrome
- Inflammatory bowel disease
- Cancer unless in complete remission for >5 years
- Proliferative retinopathy
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Pregnant or nursing women
- Known or suspected hypersensitivity to trial product or related products
- Receipt of an investigational drug within 30 days prior to visit 0
- Simultaneous participation in any other clinical intervention trial
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
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Outros nomes:
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Comparador de Placebo: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
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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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Change in HbA1c
Prazo: 6 months
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Change in HbA1c from baseline to end of study (time 6 months)
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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adverse events (including hypoglycaemic episodes)
Prazo: 6 months
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6 months
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changes in insulin dosage
Prazo: 6 months
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6 months
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|
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changes in body weight
Prazo: 6 months
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6 months
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changes in BMI
Prazo: 6 months
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6 months
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changes in body composition
Prazo: 6 months
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DXA scan measuring bonemineral density
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6 months
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changes in body composition
Prazo: 6 months
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DXA scan measuring lean mass
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6 months
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changes in body composition
Prazo: 6 months
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DXA scan measuring fat mass
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6 months
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changes in fasting plasma glucose
Prazo: 6 months
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6 months
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changes in post prandial plasma glucose
Prazo: 6 months
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6 months
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changes in fasting plasma levels of C-peptide
Prazo: 6 months
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6 months
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Quality of life self reported
Prazo: 6 months
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Quality of Life Questionaire
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6 months
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Treatment satisfaction
Prazo: 6 months
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Diabetes treatment satisfactory questionnaire status version
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6 months
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Treatment satisfaction
Prazo: 6 months
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Diabetes treatment satisfactory questionnaire change version
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6 months
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dietary patterns
Prazo: 6 months
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Food frequency questionaire three times during the intervention
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6 months
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HDL (High Density Lipoprotein)
Prazo: 6 months
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6 months
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LDL (Low Density Lipoprotein)
Prazo: 6 months
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6 months
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VLDL (Very Low Density Lipoprotein)
Prazo: 6 months
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6 months
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Colesterol total
Prazo: 6 meses
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6 meses
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triglycerides
Prazo: 6 months
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6 months
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proBNP (Pro-Brain Natriuretic Peptide)
Prazo: 6 months
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6 months
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hsCRP (High-Sensitivity C-Reactive Protein)
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- Johansen NJ, Dejgaard TF, Lund A, Vilsboll T, Andersen HU, Knop FK. Protocol for Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetes Cases (The MAG1C trial): a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2018 Jun 27;8(6):e021861. doi: 10.1136/bmjopen-2018-021861.
- Johansen NJ, Dejgaard TF, Lund A, Schluntz C, Frandsen CS, Forman JL, Wewer Albrechtsen NJ, Holst JJ, Pedersen-Bjergaard U, Madsbad S, Vilsboll T, Andersen HU, Knop FK. Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):313-324. doi: 10.1016/S2213-8587(20)30030-9. Epub 2020 Mar 2.
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
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças do Sistema Endócrino
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 1
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Anti-Obesidade
- Incretinas
- Exenatida
Outros números de identificação do estudo
- Eudract-nr.: 2016-001365-92
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