Clinical trial NCT00835861: Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Official title: Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Insulin Dependent Diabetes
Pregnancy
Keywords: Non Insulin Dependent Diabetes
Pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: WakeMed Health and Hospitals
First posted: 2009-02-04
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Blood Glucose Measurements
timeFrame: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
Secondary outcomes:
measure: Number of Patients With Obstetric Complications
timeFrame: Throughout pregnancy until hospital discharge following delivery.
measure: Maternal Weight Gain
timeFrame: Baseline throughout pregnancy until last prenatal visit.
measure: Number of Babies With Neonatal Hypoglycemia
timeFrame: Time of delivery through hospital discharge
measure: Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
timeFrame: 1st, 2nd, and 3rd trimester
measure: Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
timeFrame: Baseline throughout pregnancy until time of delivery
measure: Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
timeFrame: Baseline throughout pregnancy until time of delivery
measure: Number of Episodes Maternal Hypoglycemia
timeFrame: Baseline throughout pregnancy until time of delivery
measure: Number of Babies With Adverse Neonatal Outcomes
timeFrame: Delivery until hospital discharge
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals Obstetric Clinics
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ashley Hickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hickman MA, McBride R, Boggess KA, Strauss R. Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Am J Perinatol. 2013 Jun;30(6):483-90. doi: 10.1055/s-0032-1326994. Epub 2012 Oct 24.