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Insulin icodec for blood sugar control in adults with type 1 diabetes

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

Observational Novo Nordisk A/S · NCT07160816

This study will try insulin icodec in adults with type 1 diabetes who haven't used it before to see how well it controls blood sugar during routine care.

Quick facts

Study typeObservational
Enrollment245 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations37 sites (Pirna, LÄK Sachsen and 36 other locations)
Trial IDNCT07160816 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world study following adults with type 1 diabetes who have already decided with their doctor to start commercially available insulin icodec. Participants will receive insulin icodec per usual clinical practice and attend visits and data collection over about 22 to 30 weeks. The study enrolls adults (≥18 years) with type 1 diabetes diagnosed at least one year earlier who have been on multiple daily injections for at least six months and have a recent HbA1c. There is no randomization or experimental assignment by the sponsor; data about glucose control and routine management will be recorded as patients are treated by their own clinicians.

Who should consider this trial

Good fit: Adults aged 18 or older with type 1 diabetes for at least one year who have been on multiple daily insulin injections for six months or more and who, together with their doctor, have independently decided to start insulin icodec are ideal candidates.

Not a fit: People under 18, those with very recent diagnosis of type 1 diabetes, those not on a multiple daily injection regimen, or those who have already used insulin icodec are unlikely to be eligible or to gain information from this specific study.

Why it matters

Potential benefit: If successful, the study could show whether starting insulin icodec helps improve or stabilize blood sugar control and may simplify insulin routines for some adults with type 1 diabetes.

How similar studies have performed: Once-weekly basal insulin approaches including insulin icodec have shown promising results in type 2 diabetes studies, but published data in type 1 diabetes are more limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Pirna, LÄK Sachsen and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.