NCT05823948 (ONWARDS 9) is a Phase 3 clinical trial of Insulin Icodec in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT05823948?

NCT05823948 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT05823948?

Interventions in NCT05823948: Insulin Icodec.

What condition does NCT05823948 study?

NCT05823948 studies Diabetes Mellitus, Type 2.

Is NCT05823948 still recruiting?

NCT05823948 is currently completed. Last updated 2 December 2025.

Last reviewed 2025-12-02 · How we verify

NCT05823948: ONWARDS 9

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)

Completed Phase 3 Last updated 2 December 2025

What this trial tests

Phase 3 trial testing Insulin Icodec in Diabetes Mellitus, Type 2 in 51 participants. Completed in 11 April 2024.

Timeline

11 April 2023

Primary endpoint
6 March 2024

11 April 2024

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	11 April 2023
Primary completion	6 March 2024
Estimated completion	11 April 2024
Sites	20 locations across United States

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

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be injected with a needle in a skin fold in the thigh, upper arm, or stomach. The study will last for about 8 months. Participants will have to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The Basis for Weekly Insulin Therapy: Evolving Evidence With Insulin Icodec and Insulin Efsitora Alfa.
Rosenstock J, Juneja R, Beals JM, Moyers JS, et al · · 2024 · cited 51× · PMID 38224978 · DOI 10.1210/endrev/bnad037
Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial.
Bergenstal RM, Ásbjörnsdóttir B, Johanning Bari T, Hulkund S, et al · · 2025 · cited 2× · PMID 40040516 · DOI 10.1089/dia.2025.0050
2024 Diabetes Technology Meeting Abstracts
· 2025

Verify or expand the search:

Other trials of Insulin Icodec

Trials testing the same drug.

NCT06807190 — General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus · recruiting
NCT05813912 — A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the · Phase 3 · completed
NCT04770532 — A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, I · Phase 3 · completed
NCT04582435 — A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabe · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05823948 (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: 2 December 2025

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/NCT05823948.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing