Trials / Completed
CompletedNCT03770767
Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Faster-acting Aspart insulin Fiasp | Randomization to treatment with insulin Fiasp |
| DRUG | Control (insulin Novorapid) | Randomization to standard treatment with insulin Novorapid |
Timeline
- Start date
- 2019-11-11
- Primary completion
- 2023-03-23
- Completion
- 2023-03-23
- First posted
- 2018-12-10
- Last updated
- 2023-05-06
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03770767. Inclusion in this directory is not an endorsement.