Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes (MIPOD)
21 de abril de 2017 atualizado por: University of North Carolina, Chapel Hill
Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
31
Estágio
- Fase 2
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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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina Hospitals Obstetric Clinics
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
- Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
- Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- Less than 24 weeks at study enrollment
- Singleton or twin pregnancy
- English or Spanish speaking
- Able to give informed consent
Exclusion Criteria:
- End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- Prior need for insulin for glycemic control
- History of diabetic ketoacidosis (DKA) or hyperosmolar state
- Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- Kidney or liver disease
- Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
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 |
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Experimental: Metformin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation.
After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
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Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education.
They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy.
At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control.
If glycemic control can not be achieved with Metformin as a single agent insulin will be added.
Outros nomes:
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Comparador Ativo: Insulin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation.
After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
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Women randomized to the Insulin group will receive standard diet and glycemic monitoring education.
They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner.
At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
Outros nomes:
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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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Blood Glucose Measurements
Prazo: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
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Patients self monitored glucose measures throughout pregnancy to aid glycemic control.
Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
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Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Patients With Obstetric Complications
Prazo: Throughout pregnancy until hospital discharge following delivery.
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Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
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Throughout pregnancy until hospital discharge following delivery.
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Maternal Weight Gain
Prazo: Baseline throughout pregnancy until last prenatal visit.
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Baseline throughout pregnancy until last prenatal visit.
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Number of Babies With Neonatal Hypoglycemia
Prazo: Time of delivery through hospital discharge
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Initial neonatal glucose < 40 mg/dL
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Time of delivery through hospital discharge
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Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Prazo: 1st, 2nd, and 3rd trimester
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1st, 2nd, and 3rd trimester
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Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
Prazo: Baseline throughout pregnancy until time of delivery
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NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95
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Baseline throughout pregnancy until time of delivery
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Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
Prazo: Baseline throughout pregnancy until time of delivery
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NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130
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Baseline throughout pregnancy until time of delivery
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Number of Episodes Maternal Hypoglycemia
Prazo: Baseline throughout pregnancy until time of delivery
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Maternal glucose < 60 mg/dL
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Baseline throughout pregnancy until time of delivery
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Number of Babies With Adverse Neonatal Outcomes
Prazo: Delivery until hospital discharge
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Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.
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Delivery until hospital discharge
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ashley Hickman, MD, University of North Carolina, Chapel Hill
Publicações e links úteis
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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 agosto de 2008
Conclusão Primária (Real)
1 de fevereiro de 2010
Conclusão do estudo (Real)
1 de abril de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
2 de fevereiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de fevereiro de 2009
Primeira postagem (Estimativa)
4 de fevereiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de abril de 2017
Última verificação
1 de abril de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UNC08-0898
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