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

NCT07076199
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
877
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Lead sponsor
Novo Nordisk A/S
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Start date
2025-08-11
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Number of sites
182
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Summary
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
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Acronym
ONWARDS 11
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Short 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
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Official 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-03-01
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First posted
2025-07-22
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Registry last updated
2026-09-25
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Primary completion date
2027-01-25
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Start date
2025-08-11
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Participants
877
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Participant count basis
Estimated
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Planned participants
877
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Protocol amendments
0
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Number of sites
182
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07076199
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ClinicalTrials.gov ID
NCT07076199
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Change in glycosylated haemoglobin (HbA1c)

    Timeframe: From baseline (week 0) to week 26

    Measured in percentage (%)-points.

  1. Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))

    Timeframe: From baseline (week-2-0) to week 22-26

    Measured in %-points.

  2. Time spent less than (<)3.0 mmol/L (54 mg/dL)

    Timeframe: From week 22 to week 26

    Measured in % of time.

  3. Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)

    Timeframe: From baseline (week-2-0) to week 22-26

    Measured in %-points.

  4. Number of severe hypoglycaemic episodes (level 3)

    Timeframe: From baseline (week 0) to week 31

    Measured as number of episodes.

  5. Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)

    Timeframe: From baseline (week 0) to week 31

    Measured as number of episodes.

  6. 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)

    Timeframe: From baseline (week 0) to week 31

    Measured as number of episodes.

  7. Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])

    Timeframe: From baseline (week 0) to week 31

    Measured as number of episodes.

  8. Mean total weekly insulin dose

    Timeframe: From week 24 to week 26

    Measured in insulin units.

  9. Change in body weight

    Timeframe: From baseline (week 0) to week 26

    Measured in Kilogram (kg).

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Cullman Clinical TrialsCullman, United States
  • John Muir HealthConcord, United States
  • Headlands Research California, LLCEscondido, United States
  • Clinical Res of Central CaFresno, United States
  • Providence Medical FoundationFullerton, United States
  • Scripps Whittier Diabetes InstLa Jolla, United States
  • Loma Linda University Faculty Medical ClinicsLoma Linda, United States
  • Pacific Clinical StudiesLos Alamitos, United States
  • Los Angeles Institute for Metabolic ResearchLos Angeles, United States
  • Pasadena Clinical TrialsPasadena, United States
  • WestenU HealthPomona, United States
  • Alliance Clinical NetworkSan Diego, United States
  • Mills Health CenterSan Mateo, United States
  • Center for Endocrine DM and Metabolic DisordersSanta Clarita, United States
  • University Clin InvestigatorsTustin, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Denver Endocrinology Diabetes and Thyroid CenterEnglewood, United States
  • Optumcare Clinical Trials,LLC-GoldenGolden, United States
  • Northeast Research InstituteFleming Island, United States
  • Encore Medical Research LLCHollywood, United States
  • Northeast Research InstituteJacksonville, United States
  • Life Spring Research Foundation LLCMiami, United States
  • Suncoast Clinical Research, Inc.New Port Richey, United States
  • West Orange EndocrinologyOcoee, United States
  • Suncoast Clinical Research, Inc.Palm Harbor, United States

And 157 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-519945-31
  • U1111-1310-7017
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (1)