Metformin in Gestational Diabetes Mellitus (MetGDM)
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ClinicalTrials.gov Identifier: NCT00681460 |
Recruitment Status
:
Completed
First Posted
: May 21, 2008
Last Update Posted
: May 27, 2015
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes, Gestational Insulin Resistance | Drug: human recombined insulin Drug: metformin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial. |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
gestational diabetes, insulin therapy
|
Drug: human recombined insulin
multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status
|
Experimental: 2
gestational diabetes, metformin therapy
|
Drug: metformin
pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg
|
- newborn weight [ Time Frame: first hour of life ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681460
Poland | |
Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences | |
Poznan, Poland, 60-535 |
Study Chair: | Jacek Brazert, MD.PhD.prof | K Marcinkowski University of Med Sciences, Poznan, Poland | |
Study Director: | Antoni J Duleba, MD.prof | University of California at Davis, Sacramento, CA, USA |
Responsible Party: | Agnieszka Zawiejska, MD, PhD, Department of Obstetrics and Women's Diseases, Senior Lecturer, K. Marcinkowski University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00681460 History of Changes |
Other Study ID Numbers: |
KMUMS 705/07 |
First Posted: | May 21, 2008 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 2015 |
Keywords provided by Agnieszka Zawiejska, MD, PhD, K. Marcinkowski University of Medical Sciences:
gestational diabetes birth weight fetal growth insulin resistance |
oxidative stress inflammatory reaction Fetal Development |
Additional relevant MeSH terms:
Diabetes, Gestational Diabetes Mellitus Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
Pregnancy Complications Insulin, Globin Zinc Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs |