Trials / Completed
CompletedNCT03377699
Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 225 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin degludec | Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months |
| DRUG | Insulin Aspart | 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 |
| DRUG | Insulin detemir | 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 |
Timeline
- Start date
- 2017-11-22
- Primary completion
- 2020-12-17
- Completion
- 2020-12-17
- First posted
- 2017-12-19
- Last updated
- 2023-01-20
- Results posted
- 2022-04-27
Locations
71 sites across 15 countries: Argentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, Greece, Ireland, Israel, Italy, Russia, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03377699. Inclusion in this directory is not an endorsement.