Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

NCT00678080 | Completed Results

• 1 other identifier: HSC-MS-08-0015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy Complications

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  during third trimester

• 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.

  at the time of delivery

Secondary Outcomes (8)

• Body Mass Index

  at the time of delivery

• Number of Participants With Hypoglycemia

  During pregnancy

• Number of Participants Who Failed Metformin Therapy

  Duration of pregnancy

• Number of Participants Who Had a Cesarean Section

  At the time of delivery

• Number of Participants With Fetus With Macrosomia

  At the time of delivery

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin therapy as prescribed by their health care provider

Drug: Metformin

Insulin

ACTIVE COMPARATOR

Insulin as prescribed by their health care provider

Drug: Insulin (NPH and Regular)

Interventions

Metformin DRUG

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

Also known as: Glucophage

Metformin

Insulin (NPH and Regular) DRUG

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

Insulin

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (3)

Valley Baptist Hospital

Brownsville, Texas, 78520, United States

Location

Lyndon B Johnson Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Metformin; Insulin

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Jerrie Refuerzo, M.D.
• Organization: UT Health

jerrie.s.refuerzo@uth.tmc.edu

713-500-6416

Study Officials

• Jerrie S Refuerzo, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Ob/Gyn Maternal Fetal

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 28, 2018
• Results First Posted: November 28, 2018

Record last verified: 2018-11

Locations

US (3)