Metformin in Gestational Diabetes Mellitus (MetGDM)

K. Marcinkowski University of Medical Sciences

Status: Completed

Conditions: Diabetes, Gestational; Insulin Resistance

Treatments: Drug: human recombined insulin; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00681460

KMUMS 705/07

Details and patient eligibility

About

Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.

In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.

Enrollment: 78 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diabetes diagnosed during pregnancy
• single pregnancy
• ineffective diet therapy

Exclusion criteria

• pregestational diabetes
• fetal malformation
• multiple pregnancy
• contraindications to metformin therapy (liver or kidney disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

1

Active Comparator group

Description:

gestational diabetes, insulin therapy

Treatment:

Drug: human recombined insulin

2

Experimental group

Description:

gestational diabetes, metformin therapy

Treatment:

Drug: metformin