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New weekly insulin treatment for type 2 diabetes management

A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification

Phase 3 Interventional Novo Nordisk A/S · NCT05813912

This study is testing a new weekly insulin treatment along with another medication to see if it helps people with type 2 diabetes lower their blood sugar levels better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment148 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations41 sites (Broumov and 40 other locations)
Trial IDNCT05813912 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a new weekly insulin, insulin icodec, in conjunction with semaglutide, to lower blood sugar levels in patients with type 2 diabetes. Participants will initially receive insulin icodec for 26 weeks, and if their blood sugar levels do not normalize, they will enter a second 26-week phase where they will receive both insulin icodec and semaglutide weekly. The study will last approximately 13 months, during which participants will monitor their blood sugar levels using provided glucose meters. The goal is to assess the combined impact of these medications on glycemic control.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with type 2 diabetes for at least 180 days, with specific HbA1c levels and currently on basal insulin therapy.

Not a fit: Patients with a history of pancreatitis or recent myocardial infarction or stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood sugar management for patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promise with similar insulin and GLP-1 receptor agonist combinations, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days prior to the day of screening
* HbA1c from 7.5%-10.5% (58-91 millimoles per mole \[mmol/mol\]) (both inclusive)
* Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) \>= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses \>= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs)

Exclusion Criteria:

* Presence or history of pancreatitis (acute or chronic) within 180 days before screening
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation
* Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
* Planned coronary, carotid or peripheral artery revascularization
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Where this trial is running

Broumov and 40 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 2
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.