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Active, not recruiting

NCT Number: NCT07076199

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Macquarie University - Clinical Trials Unit, Macquarie Park, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Insulin icodec

Drug

Insulin icodec will be administered as subcutaneous injection

insulin glargine

Drug

Insulin glargine will be administered as subcutaneous injection.

insulin aspart

Drug

Insulin aspart will be administered as a subcutaneous injection.

Primary outcomes

  1. Change in glycosylated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to week 26

    Measured in percentage (%)-points.

Secondary outcomes

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

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

    Measured in %-points.

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

    Time frame: From week 22 to week 26

    Measured in % of time.

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

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

    Measured in %-points.

  4. Number of severe hypoglycaemic episodes (level 3)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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])

    Time frame: From baseline (week 0) to week 31

    Measured as number of episodes.

  8. Mean total weekly insulin dose

    Time frame: From week 24 to week 26

    Measured in insulin units.

  9. Change in body weight

    Time frame: From baseline (week 0) to week 26

    Measured in Kilogram (kg).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: ONWARDS 11

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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