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Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Primary Purpose

Pregnancy Complications

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Metformin

Insulin (NPH and Regular)

About this trial

This is an interventional treatment trial for Pregnancy Complications focused on measuring Type 2 diabetes mellitus, Pregnancy, Metformin, Insulin, Pregnant women

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
Treatment with diet or oral hypoglycemic agents prior to pregnancy.
Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
Hemoglobin A1C <9%

Exclusion Criteria:

Gestational age greater than 20 weeks
Multiple gestations (twins or more gestations)
Type 1 diabetes by patient history
Known fetal chromosomal or structural defects
Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
Those with a hemoglobin A1C greater than 9%.
On insulin at the start of pregnancy

Sites / Locations

Valley Baptist Hospital
Lyndon B Johnson Hospital
Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metformin

Insulin

Arm Description

Metformin therapy as prescribed by their health care provider

Insulin as prescribed by their health care provider

Outcomes

Primary Outcome Measures

The Number of Participants Who Achieved a Hemoglobin A1C <7%

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

The Number of Participants Who Achieved a Hemoglobin A1C <7%

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Secondary Outcome Measures

Body Mass Index

Number of Participants With Hypoglycemia

Defined as hypoglycemia as documented by neonatal chart based on health care provider description

Number of Participants Who Failed Metformin Therapy

Those whose glucose levels were above target range thereby needing insulin therapy

Number of Participants Who Had a Cesarean Section

Number of Participants With Fetus With Macrosomia

Number of Participants With Shoulder Dystocia

Number of Participants Who Had a Newborn With Respiratory Distress Syndrome

Number of Participants With Newborns Who Needed Neonatal Dextrose

Full Information

NCT ID

NCT00678080

First Posted

May 8, 2008

Last Updated

November 1, 2018

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT00678080

Brief Title

Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Official Title

A Randomized, Controlled Trial of Metformin Versus Insulin in Women With Type 2 Diabetes Mellitus During Pregnancy in a Population With Severe Health Disparities

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

Detailed Description

Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these pregnancy complications. Currently, insulin is the primary medication used to treat pregnant women with T2DM. However, it is administered by injection several times a day and compliance is low in health disparity populations with high rates of obesity and diabetes. Insulin also has the potential to lead to dangerously low blood sugars. Metformin is a medication than can be administered as pills and is not associated with dangerous low blood sugars. In addition, this insulin sensitizer is the medication of choice for women who are obese and have T2DM outside of pregnancy. We hypothesize that metformin will achieve similar levels of blood sugar control compared to insulin. In doing so, metformin will prevent the increased risk of pregnancy complications associated with T2DM in pregnancy. The aims of this study is to determine if in pregnant women with T2DM, metformin achieves similar glycemic control, and similar maternal and neonatal outcomes when compared to insulin. We propose a pilot study of a randomized, controlled trial of metformin versus insulin in the treatment of T2DM during pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Complications

Keywords

Type 2 diabetes mellitus, Pregnancy, Metformin, Insulin, Pregnant women

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

Metformin therapy as prescribed by their health care provider

Arm Title

Insulin

Arm Type

Active Comparator

Arm Description

Insulin as prescribed by their health care provider

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Glucophage

Intervention Description

Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily

Intervention Type

Drug

Intervention Name(s)

Insulin (NPH and Regular)

Intervention Description

Insulin will be administered based on maternal gestational age and maternal weight using NPH and Regular insulin. It will be administered subcutaneously 3 times a day

Primary Outcome Measure Information:

Title

The Number of Participants Who Achieved a Hemoglobin A1C <7%

Description

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Time Frame

during third trimester

Title

The Number of Participants Who Achieved a Hemoglobin A1C <7%

Description

The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes.

Time Frame

at the time of delivery

Secondary Outcome Measure Information:

Title

Body Mass Index

Time Frame

at the time of delivery

Title

Number of Participants With Hypoglycemia

Description

Defined as hypoglycemia as documented by neonatal chart based on health care provider description

Time Frame

During pregnancy

Title

Number of Participants Who Failed Metformin Therapy

Description

Those whose glucose levels were above target range thereby needing insulin therapy

Time Frame

Duration of pregnancy

Title

Number of Participants Who Had a Cesarean Section

Time Frame

At the time of delivery

Title

Number of Participants With Fetus With Macrosomia

Time Frame

At the time of delivery

Title

Number of Participants With Shoulder Dystocia

Time Frame

At the time of delivery

Title

Number of Participants Who Had a Newborn With Respiratory Distress Syndrome

Time Frame

Neonatal period

Title

Number of Participants With Newborns Who Needed Neonatal Dextrose

Time Frame

Neonatal period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

52 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history Treatment with diet or oral hypoglycemic agents prior to pregnancy. Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery. Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values. Hemoglobin A1C <9% Exclusion Criteria: Gestational age greater than 20 weeks Multiple gestations (twins or more gestations) Type 1 diabetes by patient history Known fetal chromosomal or structural defects Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis. Those with a hemoglobin A1C greater than 9%. On insulin at the start of pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerrie S Refuerzo, M.D.

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Valley Baptist Hospital

City

Brownsville

State/Province

Texas

ZIP/Postal Code

78520

Country

United States

Facility Name

Lyndon B Johnson Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77026

Country

United States

Facility Name

Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

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