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Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values |
|
| insulin | Active Comparator | NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | metformin 1 g twice daily or maximum tolerated dose less than 2 g daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight Per Arm | birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Induced Hypertension Per Arm | Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg | up to on the average 40 weeks of gestation |
| Maternal Weight Gain Per Arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tapani Rönnemaa, MD, PhD | Professor, Chief Physician | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34059525 | Derived | Huhtala MS, Ronnemaa T, Pellonpera O, Tertti K. Cord serum metabolome and birth weight in patients with gestational diabetes treated with metformin, insulin, or diet alone. BMJ Open Diabetes Res Care. 2021 May;9(1):e002022. doi: 10.1136/bmjdrc-2020-002022. | |
| 32652973 | Derived | Huhtala MS, Tertti K, Juhila J, Sorsa T, Ronnemaa T. Metformin and insulin treatment of gestational diabetes: effects on inflammatory markers and IGF-binding protein-1 - secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2020 Jul 11;20(1):401. doi: 10.1186/s12884-020-03077-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Arm | |
| FG001 | Insulin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily |
| BG001 | Insulin | insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Birth Weight Per Arm | birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies | Posted | Mean | Standard Deviation | g | delivery |
|
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Fetal cardiac function evaluated with ultrasound and cardiotokography
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fetal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Fetal death at 39 weeks due to umbilical cord complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kristiina Tertti | Department of Obstetrics and Gynecology, Turku University Central Hospital | +358 2 3130000 | kristiina.tertti@tyks.fi |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D007328 | Insulin |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011384 |
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| insulin | Drug | subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery |
|
|
| up to on the average 40 weeks of gestation |
| Pre-eclampsia Per Arm | up to on the average 40 weeks of gestation |
| Mode of Delivery Per Arm | delivery |
| Gestational Weeks at Delivery Per Arm | delivery |
| Induction of Delivery Per Arm | delivery |
| Shoulder Dystocia Per Arm | delivery |
| Neonatal Hypoglycemia Per Arm | 0-24 h after delivery |
| Neonatal Hyperbilirubinemia Per Arm | 0-3 days after delivery |
| Apgar Score at 5 Min After Delivery Per Arm | Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome | 5 minutes after delivery |
| Neonate Transfer to Intensive Care Unit Per Arm | 0-5 days after delivery |
| Child Outcome at 2 Years Per Arm | neuropsychological and motor skills testing | 2 years after birth |
| 30227169 | Derived | Huhtala MS, Tertti K, Pellonpera O, Ronnemaa T. Amino acid profile in women with gestational diabetes mellitus treated with metformin or insulin. Diabetes Res Clin Pract. 2018 Dec;146:8-17. doi: 10.1016/j.diabres.2018.09.014. Epub 2018 Sep 15. |
| 26439816 | Derived | Pellonpera O, Ronnemaa T, Ekblad U, Vahlberg T, Tertti K. The effects of metformin treatment of gestational diabetes on maternal weight and glucose tolerance postpartum--a prospective follow-up study. Acta Obstet Gynecol Scand. 2016 Jan;95(1):79-87. doi: 10.1111/aogs.12788. Epub 2015 Nov 8. |
| 24633859 | Derived | Tertti K, Laine K, Ekblad U, Rinne V, Ronnemaa T. The degree of fetal metformin exposure does not influence fetal outcome in gestational diabetes mellitus. Acta Diabetol. 2014 Oct;51(5):731-8. doi: 10.1007/s00592-014-0570-6. Epub 2014 Mar 16. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Pregnancy Induced Hypertension Per Arm | Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg | Posted | Number | participants | up to on the average 40 weeks of gestation |
|
|
|
| Secondary | Maternal Weight Gain Per Arm | Posted | Mean | Standard Deviation | kg | up to on the average 40 weeks of gestation |
|
|
|
| Secondary | Pre-eclampsia Per Arm | Posted | Number | participants | up to on the average 40 weeks of gestation |
|
|
|
| Secondary | Mode of Delivery Per Arm | Posted | Number | no of cesarean section | delivery |
|
|
|
| Secondary | Gestational Weeks at Delivery Per Arm | Posted | Mean | Standard Deviation | weeks | delivery |
|
|
|
| Secondary | Induction of Delivery Per Arm | Posted | Number | participants | delivery |
|
|
|
| Secondary | Shoulder Dystocia Per Arm | Posted | Number | participants | delivery |
|
|
|
| Secondary | Neonatal Hypoglycemia Per Arm | Posted | Number | participants | 0-24 h after delivery |
|
|
|
| Secondary | Neonatal Hyperbilirubinemia Per Arm | Posted | Number | participants | 0-3 days after delivery |
|
|
|
| Secondary | Apgar Score at 5 Min After Delivery Per Arm | Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome | Posted | Mean | Standard Deviation | units on a scale | 5 minutes after delivery |
|
|
|
| Secondary | Neonate Transfer to Intensive Care Unit Per Arm | Posted | Number | participants | 0-5 days after delivery |
|
|
|
| Secondary | Child Outcome at 2 Years Per Arm | neuropsychological and motor skills testing | Not Posted | 2 years after birth |
| 1 |
| 110 |
| 0 |
| 110 |
| EG001 | Insulin | insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery | 0 | 107 | 0 | 107 |
|
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |