Does metformin improve pregnancy outcome used by women with type 1 diabetes?

Metformin use to improve pregnancy outcome in women with type 1 diabetes. A double-blind placebo-controlled multicenter study.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005031-32-FI

Enrollment

200

Registered

2017-09-29

Start date

2017-10-10

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy of a women dealing with type 1 diabetes MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861

Interventions

Trade Name: Diformin retard Product Name: Metformin Product Code: A10BA02 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A pregnancy of a women dealing with type 1 diabetes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study are a twin pregnancy, another significant underlying disease, severe complications of diabetes, substance abuse problems, smoking, underweight or strong early pregnancy nausea.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to find out weather metformin ease insulin resistance during pregnancy in women deling with type 1 diabetes. The first endpoint of the study is the reduction of insulin requirement for more than 15% between the metformin and placebo group. ;Secondary Objective: The secondary endpoints are to demonstrate if metformin improves pregnancy prognosis by reducing the number of macrosomic and frail newborns, and reduce the risk of pregnancy and delivery complications and whether it improves maternal blood glucose level. Pregnancy complications include pre-eclampsia, gestational hepatosis, worsening proteinuria, fetal macrosomia, fetal growth retardation, intrauterine fetal death and premature deliveries. To describe labor results and complications as the percentages of cesarean sections (elective and emergent), vacuum extractions, spontaneous deliveries, shoulder dystocias, lacerations of third and fourth degree and blood loss during labor are collected. Morbities of the newborns are described by birth weight, Apgar scores, umbilical artery pH, gestational weeks at birth, NICU transmissions, the incidence of hypoglycemia and other major problems of neonatal period. ;Primary end point(s): Ensisijaisena päätetapahtumana on insuliinin tarpeen väheneminen.	—

Measure

Time frame

Main Objective: The objective of the study is to find out weather metformin ease insulin resistance during pregnancy in women deling with type 1 diabetes. The first endpoint of the study is the reduction of insulin requirement for more than 15% between the metformin and placebo group. ;Secondary Objective: The secondary endpoints are to demonstrate if metformin improves pregnancy prognosis by reducing the number of macrosomic and frail newborns, and reduce the risk of pregnancy and delivery complications and whether it improves maternal blood glucose level. Pregnancy complications include pre-eclampsia, gestational hepatosis, worsening proteinuria, fetal macrosomia, fetal growth retardation, intrauterine fetal death and premature deliveries. To describe labor results and complications as the percentages of cesarean sections (elective and emergent), vacuum extractions, spontaneous deliveries, shoulder dystocias, lacerations of third and fourth degree and blood loss during labor are collected. Morbities of the newborns are described by birth weight, Apgar scores, umbilical artery pH, gestational weeks at birth, NICU transmissions, the incidence of hypoglycemia and other major problems of neonatal period. ;Primary end point(s): Ensisijaisena päätetapahtumana on insuliinin tarpeen väheneminen.

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Secondary

Measure	Time frame
Secondary end point(s): Toissijaisena tavoitteena on selvittää parantaako metformiinihoito raskauden sokeritasapainoa ja veren lipidiprofiilia ja vaikuttaako hoito verenkierron inflammaatiomarkkereihin.	—

Countries

Finland

Contacts

Public ContactDep Obstetrics and gynecology

Tampere University Hospital

kati.tihtonen@pshp.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026