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NCT Number: NCT07112339

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centricity Research Calgary Endocrinology, Calgary, Alberta, Canada

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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 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.

Treatment and study plan

Insulin icodec

Drug

Insulin icodec will be administered as subcutaneous injection.

Basal insulin analogues

Drug

Basal insulin analogues will be administered as subcutaneous injection.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline week 0 to week 52

    Measured as %-point.

Secondary outcomes

  1. Adelphi Adherence Questionnaire (ADAQ©)

    Time frame: At week 52

    Measured as Score. The ADAQ© score is calculated as the mean of 11 individual items, each rated on a scale from 0 to 4. To obtain the mean score, at least 8 of these items must be answered. A lower score indicates greater adherence.

  2. Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction

    Time frame: From baseline week 0 to week 52

    Measured as Score of 0-36. DTSQs score ranges from 0 to 36, based on 6 items that are each rated on a scale of 0 to 6. A higher score reflects greater satisfaction with the treatment received.

  3. Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain

    Time frame: At week 52

    Measured as Score of 4-20.The score ranges from 4 to 20, based on 4 items rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate better compliance.

  4. Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain

    Time frame: At week 52

    Measured as Score of 6-30. The score ranges from 6 to 30, derived from 6 items each rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate less treatment burden.

  5. Number of severe hypoglycaemic episodes (level 3)

    Time frame: From baseline week 0 to week 52

    Measured as Number of episodes.

  6. Mean weekly basal insulin dose

    Time frame: From week 50 to week 52

    Measures in Units.

  7. Participant achieved individualised HbA1c target

    Time frame: At week 52

    Reported as Yes or No.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 8, 2025
Registry last updated
Jun 5, 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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