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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07076199




Registration number
NCT07076199
Ethics application status
Date submitted
14/07/2025
Date registered
22/07/2025
Date last updated
2/09/2025

Titles & IDs
Public title
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
Scientific title
A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
Secondary ID [1] 0 0
U1111-1310-7017
Secondary ID [2] 0 0
NN1436-8182
Universal Trial Number (UTN)
Trial acronym
ONWARDS 11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin icodec
Treatment: Drugs - Insulin glargine
Treatment: Drugs - Insulin aspart

Experimental: Insulin icodec + insulin aspart - Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .

Active comparator: Insulin glargine+ insulin aspart - Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.


Treatment: Drugs: Insulin icodec
Insulin icodec will be administered as subcutaneous injection

Treatment: Drugs: Insulin glargine
Insulin glargine will be administered as subcutaneous injection.

Treatment: Drugs: Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in glycosylated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to week 26
Secondary outcome [1] 0 0
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Timepoint [1] 0 0
From baseline (week-2-0) to week 22-26
Secondary outcome [2] 0 0
Time spent less than (<)3.0 mmol/L (54 mg/dL)
Timepoint [2] 0 0
From week 22 to week 26
Secondary outcome [3] 0 0
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)
Timepoint [3] 0 0
From baseline (week-2-0) to week 22-26
Secondary outcome [4] 0 0
Number of severe hypoglycaemic episodes (level 3)
Timepoint [4] 0 0
From baseline (week 0) to week 31
Secondary outcome [5] 0 0
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)
Timepoint [5] 0 0
From baseline (week 0) to week 31
Secondary outcome [6] 0 0
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)
Timepoint [6] 0 0
From baseline (week 0) to week 31
Secondary outcome [7] 0 0
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])
Timepoint [7] 0 0
From baseline (week 0) to week 31
Secondary outcome [8] 0 0
Mean total weekly insulin dose
Timepoint [8] 0 0
From week 24 to week 26
Secondary outcome [9] 0 0
Change in body weight
Timepoint [9] 0 0
From baseline (week 0) to week 26

Eligibility
Key inclusion criteria
* Diagnosed with type 1 diabetes mellitus greater than or equal to (=) 1 year before screening.
* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) = 6 months before screening.
* HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
* Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products.
* Previous participation in this study. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
* Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/12/2026
Actual
Sample size
Target
877
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
Illawarra Diabetes Service Clinical Trials & Research Unit - Wollongong
Recruitment hospital [3] 0 0
Townsville University Hospital - Townsville
Recruitment hospital [4] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [5] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4814 - Townsville
Recruitment postcode(s) [4] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment outside Australia
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Alabama
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Lublin
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Opole
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Warsaw
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Zamosc
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Puerto Rico
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Bayamón
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Dolj
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Bytca
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Slovakia
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Košice

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07076199