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NCT Number: NCT07160816

A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar

The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 1 diabetes (T1D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.

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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

Observational

Primary location

Hausärztliche und Diabetologische Praxis Pirna, Pirna, LÄK Sachsen, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available insulin icodec has been made by the participant/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
  • Male or female, age greater than or equal to (≥) 18 years at the time of signing informed consent.
  • Diagnosed with T1D ≥ 1 year before signing informed consent.
  • Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before signing informed consent.
  • Available HbA1c value less than or equal to (≤) 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.
  • Treatment naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Treatment and study plan

Insulin icodec

Drug

Participants with T1D will be treated with commercially available insulin icodec.

Other names: Awiqli

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: Baseline (week 0), week 26

    Measured as percentage (%) point of HbA1c.

Secondary outcomes

  1. Change in Insulin Treatment Satisfaction Questionnaire (ITSQ) score

    Time frame: Baseline (week 0), end of study (week 22-30)

    ITSQ measures insulin treatment satisfaction, applicable to a wide range of insulin therapies. The ITSQ consists of 22 items yielding 5 domain scores and a total score. The domains consist of Regimen inconvenience (5 items), Lifestyle flexibility (3 items), Glycemic control (3 items), Hypoglycemic control (5 items), and Satisfaction with the insulin delivery device (6 items). The domain and global ITSQ score both ranges from 0-100.Higher scores indicate a better health state (less negative impact).

  2. Change in Adelphi Adherence Questionnaire (ADAQ) score

    Time frame: Baseline (week 0), end of study (week 22-30)

    The ADAQ measure consists of 11 items scored on a scale of 0 to 4. The mean of the individual items represents the total ADAQ score. At least 8 of the 11 items must be answered to calculate the ADAQ score. The lower the score corresponds to the greater adherence.

  3. Number of self-reported overall severe hypoglycaemia

    Time frame: From baseline (week 0) to end of study (week 22-30)

    Measured as number of episodes.

  4. Clinical success as perceived by the physician

    Time frame: From baseline (week 0) to end of study (week 22-30)

    Measured as count of participant per response option.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Use of Insulin Icodec in People Living With Type 1 Diabetes

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Jun 29, 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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