Diabetes Mellitus, Type 1 MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Tresiba® 100 units/ml solution for injection in pre-filled pen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit:
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion 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 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 214 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the effect on glycaemic control of insulin degludec once daily plus insulin aspart 2-4 times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times daily with meals in a population of pregnant women with type 1 diabetes mellitus.;Secondary Objective: 1. To compare the effect on maternal safety of insulin degludec once daily plus insulin aspart 2-4 times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times daily with meals in a population of pregnant women with type 1 diabetes mellitus. 2. To compare the effect on pregnancy outcome of insulin degludec once daily plus insulin aspart 2-4 times daily with meals and insulin detemir once daily or twice daily plus insulin aspart 2-4 times daily with meals in a population of pregnant women with type 1 diabetes mellitus.;Primary end point(s): 1. Last planned glycosylated haemoglobin (HbA1c) prior to delivery;Timepoint(s) of evaluation of this end point: 1. After gestational week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1.-3. After gestational week 16 4. During the pregnancy period (from first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery) 5. From treatment baseline as well as from pregnancy baseline to the end of treatment visit 6. From first day of pregnancy (date of conception) or randomisation (whichever comes last) to delivery) 7. occurring from gestational week 20 to delivery 8. - 11. At birth 12. From delivery to final follow-up 13. During the first 24 hours after birth or between 24 hours and 48 hours after birth;Secondary end point(s): Supportive maternal efficacy endpoints 1. HbA1c = 6.0% (42 mmol/mol) from last planned HbA1c prior to delivery (yes/no) 2. Last planned average post-prandial glucose prior to delivery. Average of three main meals. 3. Last planned fasting plasma glucose prior to delivery Supportive maternal safety endpoints 4. Number of hypoglycaemic episodes 5. Development of sight-threatening retinopathy defined as proliferative retinopathy or maculopathy (yes/no) 6. Number of adverse events during the pregnancy period 7. Pre-eclampsia defined as new-onset hypertension (blood pressure = 140 mmHg systolic or = 90 mmHg diastolic, based on at least 2 measurements taken at least 4 hours apart)and simultaneous proteinuria (defined as = 300 mg protein in a 24 hours urine sample, a protein-to-creatinine ratio of = 300 mg/g in a urine sample or a urine dipstick protein of 1+) or presence of eclampsia, HELLP syndrome, or other severe organ involvement (yes/no) Supportive pregnancy outcome endpoints 8. Birth weight (kg) 9. Pre-term delivery (delivery < 37 completed gestational weeks) (yes/no) 10. Presence of major abnormalities (classified according to EUROCAT) (yes/no) 11. Live born infants (yes/no) 12. Number of adverse events in the infant 13. Neonatal hypoglycaemic episodes defined as plasma glucose = 1.7 mmol/L (31 mg/dL) during the first 24 hours after bi | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, European Union, Greece, Ireland, Israel, Russian Federation, Serbia, Spain, United Kingdom
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed