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NCT01892319
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed
Last updated 19 November 2019
What this trial tests
trial testing insulin detemir in Diabetes Mellitus in 2,446 participants. Completed in 30 September 2019.
Timeline
30 September 2013
Primary endpoint
30 September 2019
30 September 2019
30 September 2019
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,446 |
| Start date | 30 September 2013 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 93 locations across France, Italy, Finland, Netherlands, Greece, Malaysia, Ireland, United Kingdom |
Drugs / interventions tested
- insulin detemir (INSULIN DETEMIR) — full drug profile →
- other injectable antidiabetic treatment regimens — full drug profile →
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Eligibility, female only, with Diabetes Mellitus or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study.
Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, et al · · 2021 · cited 21× · PMID 34330786 · DOI 10.2337/dc21-0472 -
Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins.
Mathiesen ER, Andersen H, Kring SI, Damm P. · · 2017 · cited 11× · PMID 28100192 · DOI 10.1186/s12884-016-1177-4 -
56<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
· 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5 -
58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
· 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w -
Glycemic Control and Risk of Congenital Malformations in Women With Type 1 Diabetes.
Thorius IH, Petersen J, Husemoen LLN, Alibegovic AC, et al · · 2024 · cited 4× · PMID 39236320 · DOI 10.1097/aog.0000000000005722
Verify or expand the search:
- PubMed search for NCT01892319
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT01892319 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 19 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01892319.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing