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

Pregnancy Clinical Trial

— MIPOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835861
• Other study ID #: UNC08-0898
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2009
• Last updated: April 21, 2017
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Non Insulin Dependent Diabetes
• Pregnancy

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals Obstetric Clinics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	WakeMed Health and Hospitals

Country where clinical trial is conducted

United States, 

Outcome

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