Metformin in Gestational Diabetes Mellitus (MetGDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00681460
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Agnieszka Zawiejska, MD, PhD, K. Marcinkowski University of Medical Sciences

May 19, 2008
May 21, 2008
May 27, 2015
May 2008
April 2013   (Final data collection date for primary outcome measure)
newborn weight [ Time Frame: first hour of life ]
Same as current
Complete list of historical versions of study NCT00681460 on Archive Site
parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth, [ Time Frame: during pregnancy and up to twelve hours after delivery ]
Same as current
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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.

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.

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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes, Gestational
  • Insulin Resistance
  • 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
  • Active Comparator: 1
    gestational diabetes, insulin therapy
    Intervention: Drug: human recombined insulin
  • Experimental: 2
    gestational diabetes, metformin therapy
    Intervention: Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
April 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
KMUMS 705/07
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Agnieszka Zawiejska, MD, PhD, K. Marcinkowski University of Medical Sciences
K. Marcinkowski University of Medical Sciences
Not Provided
Study Chair: Jacek Brazert, K Marcinkowski University of Med Sciences, Poznan, Poland
Study Director: Antoni J Duleba, University of California at Davis, Sacramento, CA, USA
K. Marcinkowski University of Medical Sciences
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP