Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin degludec; Insulin Aspart; Insulin detemir
Intervention description: Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months; Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months; Injection for subcutaneous (s.c., under the skin) use, once daily or twice daily. The total trial duration for subjects will be maximum 25 months
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 225.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are doing this study to see the effect of insulin degludec in pregnant
      women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin
      degludec is compared to another medicine called insulin detemir. Participants will either get
      insulin degludec or insulin detemir and take it together with a medicine called insulin
      aspart - which treatment participants get is decided by chance. Participants will get
      pre-filled insulin pens. Participants will need to take blood sugar measurements several
      times a day. The study will last between 10 and 25 months depending on whether participants
      are already pregnant when they join the study. The number of visits and the tests ( for
      example blood and urine samples and ultrasound scans) the participants will have also depends
      on whether they are pregnant at study start.
    

Eligibility criteria:

        Inclusion Criteria: - Female, age at least 18 years at the time of signing informed consent
        - Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening
        - Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous
        insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of
        screening - The subject is planning to become pregnant within 12 months from randomisation
        and willing to undertake pre-pregnancy counselling or the subject is pregnant with an
        intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any
        observed anomalies at randomisation, confirmed by an ultrasound scan - HbA1c at screening
        below or equal to 8.0% (64 mmol/mol) by central laboratory Exclusion Criteria: - Treatment
        with any medication for the indication of diabetes or obesity other than stated in the
        inclusion criteria within the past 90 days prior to the day of screening - Pregnant and
        having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300
        mg/g in urine sample measured at screening - Subject being treated or became pregnant with
        assistance of in vitro fertilisation or other medical infertility treatment - Receipt of
        any concomitant medication contraindicated in pregnancy according to local label within 28
        days before screening and between screening and randomisation for non-pregnant subjects and
        28 days before conception and between conception and randomisation for pregnant subjects -
        Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
        photography or pharmacologically dilated fundoscopy performed within the past 90 days prior
        to randomisation for non-pregnant subjects or within 28 days prior to randomisation for
        pregnant subjects. - History of severe hyperemesis gravidarum (requiring hospitalisation)