Trial Outcomes & Findings for 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) (NCT NCT05823948)
NCT ID: NCT05823948
Last Updated: 2026-04-30
Results Overview
Change in HbA1c from week 0 to week 26 is presented in percentage-point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
Baseline (week 0), week 26
Results posted on
2026-04-30
Participant Flow
The trial was conducted at 9 sites in United States of America.
The trial explores the initiation and titration of once-weekly insulin icodec using intermittently scanned continuous glucose monitoring (isCGM) device system in combination with non-insulin antidiabetic drugs in insulin-naïve participants with type 2 diabetes (T2D). The trial included up to 2 weeks of screening period, a 2-week run-in period, a 26-week intervention period and a 5-week follow-up period.
Participant milestones
| Measure |
Insulin Icodec
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
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Overall Study
STARTED
|
51
|
|
Overall Study
Full Analysis Set
|
51
|
|
Overall Study
Safety Analysis Set
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Insulin Icodec
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Insulin Icodec
n=51 Participants
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
|
Age, Continuous
|
61.27 Years
STANDARD_DEVIATION 9.90 • n=14 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), week 26Population: Full analysis set included all participants assigned to study intervention. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure.
Change in HbA1c from week 0 to week 26 is presented in percentage-point.
Outcome measures
| Measure |
Insulin Icodec
n=50 Participants
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.18 Percentage-point of HbA1c
Standard Deviation 0.91
|
Adverse Events
Insulin Icodec
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Icodec
n=51 participants at risk
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/51 • Number of events 1 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
|
Injury, poisoning and procedural complications
Snake bite
|
2.0%
1/51 • Number of events 1 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
Other adverse events
| Measure |
Insulin Icodec
n=51 participants at risk
Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
4/51 • Number of events 4 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
|
Infections and infestations
COVID-19
|
9.8%
5/51 • Number of events 5 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 3 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
7/51 • Number of events 9 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • Number of events 3 • From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER