drugset / Trial / NCT01240785
Metformin Versus Insulin in Gestational Diabetes
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2006-06
- Primary completion
- 2011-01
- Completion
- 2012-12
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Metformin | Small molecule | 1 g | Oral |