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OpenTrials
Completed

NCT Number: NCT00835861

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

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.

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Key information

Conditions

Non Insulin Dependent Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of North Carolina Hospitals Obstetric Clinics

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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.

Other names: Glucophage

Insulin

Drug

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.

Other names: Regular Insulin, Novolin R, Humulin R, NPH Insulin, Novolin N, Humulin N

Primary outcomes

  1. Blood Glucose Measurements

    Time frame: 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.

Secondary outcomes

  1. Number of Patients With Obstetric Complications

    Time frame: Throughout pregnancy until hospital discharge following delivery.

    Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.

  2. Maternal Weight Gain

    Time frame: Baseline throughout pregnancy until last prenatal visit.

  3. Number of Babies With Neonatal Hypoglycemia

    Time frame: Time of delivery through hospital discharge

    Initial neonatal glucose < 40 mg/dL

  4. Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester

    Time frame: 1st, 2nd, and 3rd trimester

  5. Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)

    Time frame: Baseline throughout pregnancy until time of delivery

    NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95

  6. Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)

    Time frame: Baseline throughout pregnancy until time of delivery

    NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130

  7. Number of Episodes Maternal Hypoglycemia

    Time frame: Baseline throughout pregnancy until time of delivery

    Maternal glucose < 60 mg/dL

  8. Number of Babies With Adverse Neonatal Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • WakeMed Health and Hospitals

Registry information

Official study title

Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)

Acronym: MIPOD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2009
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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