NN1250-4300 EXPECT
Research type
Research Study
Full title
A trial comparing the effect and safety of insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes.
IRAS ID
229942
Contact name
Rustam Rea
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2017-000048-17
Duration of Study in the UK
3 years, 5 months, 7 days
Research summary
This is a randomised (1:1), open-label, parallel, multi-centre, multi-national, treat-to-target, active controlled trial comparing the effect and safety of insulin degludec once daily plus insulin aspart 2-4 times daily with meals with insulin detemir once daily or twice daily plus insulin aspart 2-4 times daily with meals in pregnant women with T1DM.
Participants will be randomised either pre-pregnant with the intention to become pregnant or pregnant from gestational weeks 8-13 + 6 days. Randomisation will be stratified according to if the participant is pregnant or planning pregnancy at time of randomisation. Stratification will also occur for planned continued use of the participant's own continuous glucose monitoring device verses capillary glucose monitoring.
The treat-to-target design and consequent visit schedule is used in order to ensure optimal insulin titration based on self-measured plasma glucose values.
For the participants included as pregnant, there will be up to 11 clinic visits and up to 31 phone contacts. For the participants included as pre-pregnant, the number of visits and phone contacts will depend on if and when the participants become pregnant. There will be up to 17 clinic visits and 40 phone calls with the clinician or study team in the pre-pregnant phase of the study. Up to 12 more clinic visits and 37 phone calls in the pregnant phase of the study.
The study plan is to include a total of 430 randomised participants across 13 countries including the UK. In the UK, the planned number of randomised participants is 31 (10 pre-pregnant and 21 pregnant) across a possible 8 sites.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0307
Date of REC Opinion
21 Sep 2017
REC opinion
Further Information Favourable Opinion