Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes (MIPOD)

21 de abril de 2017 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

31

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina Hospitals Obstetric Clinics

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Metformin
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.
Otros nombres:
  • Glucófago
Comparador activo: 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.
Droga: Insulin
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.
Otros nombres:
  • Novolina R
  • Insulina regular
  • Humulina R
  • Humulina N
  • Novolina N
  • NPH Insulin

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Glucose Measurements
Periodo de tiempo: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
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.
Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Patients With Obstetric Complications
Periodo de tiempo: Throughout pregnancy until hospital discharge following delivery.
Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
Throughout pregnancy until hospital discharge following delivery.
Maternal Weight Gain
Periodo de tiempo: Baseline throughout pregnancy until last prenatal visit.
Baseline throughout pregnancy until last prenatal visit.
Number of Babies With Neonatal Hypoglycemia
Periodo de tiempo: Time of delivery through hospital discharge
Initial neonatal glucose < 40 mg/dL
Time of delivery through hospital discharge
Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Periodo de tiempo: 1st, 2nd, and 3rd trimester
1st, 2nd, and 3rd trimester
Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
Periodo de tiempo: Baseline throughout pregnancy until time of delivery
NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95
Baseline throughout pregnancy until time of delivery
Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
Periodo de tiempo: Baseline throughout pregnancy until time of delivery
NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130
Baseline throughout pregnancy until time of delivery
Number of Episodes Maternal Hypoglycemia
Periodo de tiempo: Baseline throughout pregnancy until time of delivery
Maternal glucose < 60 mg/dL
Baseline throughout pregnancy until time of delivery
Number of Babies With Adverse Neonatal Outcomes
Periodo de tiempo: Delivery until hospital discharge
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.
Delivery until hospital discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of North Carolina, Chapel Hill

Colaboradores

WakeMed Health and Hospitals

Investigadores

  • Investigador principal: Ashley Hickman, MD, University of North Carolina, Chapel Hill

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2008

Finalización primaria (Actual)

1 de febrero de 2010

Finalización del estudio (Actual)

1 de abril de 2010

Fechas de registro del estudio

Enviado por primera vez

2 de febrero de 2009

Primero enviado que cumplió con los criterios de control de calidad

2 de febrero de 2009

Publicado por primera vez (Estimar)

4 de febrero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

21 de abril de 2017

Última verificación

1 de abril de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UNC08-0898

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Metformin

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Jamaica

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir