A Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec

NCT07632404 | Not Yet Recruiting

• 2 other identifiers: NN1436-8501U1111-1328-4242
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 15

Brief Summary

The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 2 diabetes (T2D) 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured as percentage (%) point of HbA1c.

  Baseline (week 0), week 26

Secondary Outcomes (6)

• Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score

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

• Change in Adelphi Adherence Questionnaire (ADAQ) score

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

• Change in body weight

  Baseline (week 0), week 26

• Number of self-reported overall severe hypoglycemia episodes

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

• Frequency of titrations

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

Study Arms (1)

Insulin icodec

Participants with T2D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.

Drug: Insulin icodec

Interventions

Insulin icodec DRUG

Participants with T2D will be treated with commercially available insulin icodec.

Also known as: Awiqli

Insulin icodec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises participants who are diagnosed with type 2 diabetes and agree to be treated with insulin icodec after consultation with their physician independently from the decision to participate in this study.

You may qualify if:

• Signed consent obtained before any study-related activities (study-related activities are any procedure 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 above or equal to 18 years at the time of signing informed consent.
• Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent.
• Treated with once- or twice-daily basal insulin injections ≥ 6 months before signing informed consent. Any other antidiabetic medications are allowed, except for bolus insulin during the 90 days prior to switching to icodec for a period of 14 days or more.
• Available HbA1c within 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (15)

Azienda Sanitaria Locale Di Pescara

Pescara, Abruzzo, 65124, Italy

Location

Azienda Ospedaliera-Universitaria Di Cosenza

San Giovanni in Fiore (CS), Calabria, 87027, Italy

Location

Azienda Sanitaria Locale Napoli 2 Nord

Marano Di Napoli (NA), Campania, 80016, Italy

Location

Azienda Ospedaliera Policlinico Universitario Tor Vergata

Rome, Lazio, 00133, Italy

Location

Policlinico Casilino

Rome, Lazio, 00169, Italy

Location

Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna

Rome, Lazio, 00189, Italy

Location

Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo

Milan, Lombardy, 20142, Italy

Location

Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia

Milan, Lombardy, 20159, Italy

Location

Azienda Ospedaliera Santa Croce E Carle

Cuneo, Piedmont, 12100, Italy

Location

ARNAS Garibaldi Catania

Catania, Sicily, 95123, Italy

Location

Ospedale centrale L. Bohler Bolzano

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Azienda Ospedaliera di Padova

Padova, Veneto, 35128, Italy

Location

Ospedale di Città di Castello

Città di Castello, 06012, Italy

Location

ASL Avellino

Montoro, 83026, Italy

Location

Ospedale Generale provinciale

Province of Macerata, 62100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (15)