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Once-weekly insulin icodec versus daily basal insulin for adults with type 2 diabetes

EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice

Phase 4 Interventional Novo Nordisk A/S · NCT07112339

This test looks at whether a once-weekly injectable insulin (icodec) can keep blood sugar as well as commonly used daily basal insulins in adults with type 2 diabetes who need basal insulin.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment586 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations75 sites (Calgary, Alberta and 74 other locations)
Trial IDNCT07112339 on ClinicalTrials.gov

What this trial studies

This phase 4, post-approval comparison assigns adults with type 2 diabetes who need basal insulin intensification to receive either once-weekly insulin icodec or a commonly used daily basal insulin and follows them for about 13 months. Participants may continue allowed non-insulin glucose-lowering medications and will have regular clinic visits to monitor blood sugar control and safety. Key outcomes include HbA1c maintenance and rates of hypoglycemia and other adverse events. The trial is being run at several clinical research sites in Canada.

Who should consider this trial

Good fit: Adults with type 2 diabetes for at least six months, an HbA1c of 7% or higher within the last 90 days, currently on non-insulin glucose-lowering therapies, and judged by a clinician to need basal insulin intensification.

Not a fit: People with known hypersensitivity to the study insulins, type 1 diabetes, recent conflicting trial participation, pregnant or breastfeeding individuals, or those already well controlled on a daily insulin regimen are unlikely to gain benefit from joining this comparison.

Why it matters

Potential benefit: If successful, once-weekly icodec could reduce injection frequency while maintaining blood sugar control, potentially making insulin treatment more convenient and improving adherence.

How similar studies have performed: Earlier phase 2 and 3 trials of icodec have shown it can match daily basal insulins for A1c lowering with comparable safety, so this trial builds on those positive findings in a post-approval setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
* Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of 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 antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.

* Need of intensification with basal insulin, as indicated at the discretion of the investigator.
* Recorded HbA1c value ≥7% within the last 90 days prior to randomization.

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 child-bearing potential and not using adequate contraceptive method.
* Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
* Any disorder which in the investigator's opinion might jeopardize participant's safety.

Where this trial is running

Calgary, Alberta and 74 other locations

+25 more sites — see ClinicalTrials.gov for the full list.

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.