A comparison of the faster-acting insulin Fiasp® versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactatio

Phase 1

• Conditions: Type 1 and type 2 diabetes during pregnancy and lactation; MedDRA version: 20.0 Level: LLT Classification code 10012614 Term: Diabetes mellitus NOS System Organ Class: 100000004861; MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-004680-31-DK
• Lead Sponsor: ene Ringholm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

Women, age = 18 years
Duration of type 1 diabetes = 12 months or type 2 diabetes (any duration)
Pregnant with an intrauterine singleton living fetus (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan

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 220
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•A diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
•Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or NPH insulin and not willing to continue routine treatment modality
•Women with type 2 diabetes who before pregnancy were either treated with diet, oral antidiabetic therapy or pre-mixed insulin who are not willing to change to trial medication according to randomisation or to an appropriate long-acting insulin analog as insulin detemir, insulin degludec, insulin glargine, insulin abasaglar or insulin toujeo (as part of routine MDI therapy in type 2 diabetes), as indicated.
•No proficiency in Danish to understand oral and written information

Study & Design

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