Trial | NCT00681460  Report issue

Title

Metformin in Gestational Diabetes Mellitus
Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    78
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.
Study Started
May 31
2008
Primary Completion
Apr 30
2013
Study Completion
May 31
2013
Last Update
May 27
2015
Estimate

Drug human recombined insulin

multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status

Drug metformin

pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg

1 Active Comparator

gestational diabetes, insulin therapy

2 Experimental

gestational diabetes, metformin therapy

Criteria 

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)
No Results Posted