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NCT04582448
A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes
Phase 1 trial testing Insulin icodec in Diabetes Mellitus, Type 2 in 25 participants. Completed in 27 September 2021.
27 September 2021
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 1 October 2020 |
| Primary completion | 27 September 2021 |
| Estimated completion | 27 September 2021 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Insulin icodec — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Adults 18 to 69, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions. Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh. The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak. Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus.
Plum-Mörschel L, Andersen LR, Hansen S, Hövelmann U, et al · · 2023 · cited 20× · PMID 36631720 · DOI 10.1007/s40261-022-01243-6 -
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
Verify or expand the search:
- PubMed search for NCT04582448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Insulin icodec
Trials testing the same drug.
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
- NCT07112339 — A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in · Phase 4 · recruiting
- NCT07076199 — A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insuli · Phase 3 · recruiting
- NCT06340854 — A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reduc · Phase 3 · completed
- NCT06288412 — A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Pro · Phase 1 · completed
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · 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 NCT04582448 (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: 20 January 2023
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/NCT04582448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing