Clinical trial NCT01240785: Metformin Versus Insulin in Gestational Diabetes
Official title: Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gestational Diabetes
Keywords: gestational diabetes
metformin
insulin
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2010-11-15
Enrollment: 221
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Mothers with gestational diabetes who had at least twice plasma glucose at fasting \> 5.4 mmol/L and/or 1 hour postprandial value \> 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion Criteria:

1. Fasting glucose \> 7.0 mmol/L or 1 hour postprandial plasma glucose \> 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) \> 7.0%
2. Renal, hepatic or cardiac failure
3. Pregestational use of metformin
4. Pregnancy with multiple fetuses

Primary outcomes:
measure: Birth Weight Per Arm
timeFrame: delivery
Secondary outcomes:
measure: Pregnancy Induced Hypertension Per Arm
timeFrame: up to on the average 40 weeks of gestation
measure: Maternal Weight Gain Per Arm
timeFrame: up to on the average 40 weeks of gestation
measure: Pre-eclampsia Per Arm
timeFrame: up to on the average 40 weeks of gestation
measure: Mode of Delivery Per Arm
timeFrame: delivery
measure: Gestational Weeks at Delivery Per Arm
timeFrame: delivery
measure: Induction of Delivery Per Arm
timeFrame: delivery
measure: Shoulder Dystocia Per Arm
timeFrame: delivery
measure: Neonatal Hypoglycemia Per Arm
timeFrame: 0-24 h after delivery
measure: Neonatal Hyperbilirubinemia Per Arm
timeFrame: 0-3 days after delivery
measure: Apgar Score at 5 Min After Delivery Per Arm
timeFrame: 5 minutes after delivery
measure: Neonate Transfer to Intensive Care Unit Per Arm
timeFrame: 0-5 days after delivery
measure: Child Outcome at 2 Years Per Arm
timeFrame: 2 years after birth
Other outcomes:
Locations:
Study officials:
affiliation: Professor, Chief Physician
name: Tapani Rönnemaa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.