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

Phase 1

• Conditions: Pregnancy of a women dealing with type 1 diabetes; MedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-005031-32-FI
• Lead Sponsor: Pirkanmaan sairaanhoitopiiri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-29
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 200

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified