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NCT03723759
A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Phase 1 trial testing Faster Aspart 200 U/mL in Diabetes Mellitus, Type 1 in 56 participants. Completed in 27 March 2019.
21 March 2019
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 26 October 2018 |
| Primary completion | 21 March 2019 |
| Estimated completion | 27 March 2019 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Faster Aspart 200 U/mL — full drug profile →
- Faster aspart 100 U/mL — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Adults 18 to 64, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03723759
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
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- NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
- NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
- NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
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)
- Trial protocol + status: ClinicalTrials.gov NCT03723759 (US National Library of Medicine, public domain)
- 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: 18 March 2020
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/NCT03723759.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing