CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
Insulin degludec +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03377699
NCT03377699Phase 3Completed
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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

Novo Nordisk A/S·interventional·Posted Dec 19, 2017·Updated Jan 20, 2023

In Brief

A Phase 3 clinical trial evaluating Insulin degludec, Insulin Aspart, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 225 participants across 71 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 1
CountriesArgentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, Greece, Ireland, Israel, Italy, Russia, Serbia, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 19, 2017
Enrollment StartNov 22, 2017
Primary CompletionDec 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.5 years ago

Interventions

Insulin degludecdrug

Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months

Insulin Aspartdrug

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

Insulin detemirdrug

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