A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

June 2, 2026 updated by: Novo Nordisk A/S

Protocol Title: 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 Short Title: A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Broumov, Czechia, 550 01
        • Edumed Broumov
      • Chrudim, Czechia, 537 01
        • DIAMIN
      • Olomouc, Czechia, 779 00
        • Diabetologicke centrum s.r.o.
      • Plzeň 3, Czechia, 301 00
        • DIALINE s.r.o.
      • Prague, Czechia, 140 00
        • MEDICON a.s.
      • Prague, Czechia, 110 00
        • Diabet2 s.r.o.
      • Prague, Czechia, 140 21
        • Diabetologická a endokrinologická ambulance Praha
      • Prague, Czechia, 150 00
        • EUC Klinika Praha a.s.
      • Praha 4 - Chodov, Czechia, 148 00
        • Comfort Care Praha s.r.o.
      • Soběslav I, Czechia, 39201
        • DiaPodi care s.r.o.
  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Hospital Canselor Tuanku Muhriz UKM
    • Perak
      • Seri Manjung, Perak, Malaysia, 32040
        • Hospital Seri Manjung
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Hospital Putrajaya
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Hospital Miri
    • Selangor
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Universiti Teknologi MARA, Sungai Buloh Campus
  • Poland
      • Bialystok, Poland, 15-351
        • Osteo-Medic s.c. A. Racewicz, J. Supronik
      • Gdansk, Poland, 80-546
        • Centrum Badań Klinicznych PI-House sp. z o.o.
      • Gdansk, Poland, 80-858
        • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
      • Gdansk, Poland, 80-858
        • NZOZ Gdanska Poradnia Cukrzycowa
      • Gorzów Wielkopolski, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Lodz, Poland, 90-302
        • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
      • Warsaw, Poland, 00-710
        • Nbr Polska Tomasz Klodawski
      • Wierzchosławice, Poland, 33-122
        • Poradnia Chorob Metabolicznych w Wierzchoslawicach
      • Zabrze, Poland, 41-800
        • Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-261
        • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Metabolica Sp. z o.o.
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
    • Lubusz Voivodeship
      • Gorzów Wielkopolski, Lubusz Voivodeship, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-710
        • NBR Polska
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-302
        • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Zemun
      • Belgrade, Serbia, 11000
        • CHC Zvezdara, Clinical department for endocrinology
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital - Ped-Endo and Metabolism
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital_Diabetes and Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin Icodec + Semaglutide
Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses.
Drug: Insulin Icodec
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
Drug: Semaglutide
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (Week 26), Week 52
Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Baseline (Week 26), Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles
Time Frame: Baseline (Week 26), Week 52
Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Baseline (Week 26), Week 52
Change in Mean Post-prandial Glucose Increment (Over All Meals)
Time Frame: Baseline (Week 26), Week 52
Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Baseline (Week 26), Week 52
Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (Week 26), Week 52
Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included.
Baseline (Week 26), Week 52
Number of Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline (week 26) to week 57
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
From baseline (week 26) to week 57
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter)
Time Frame: From baseline (week 26) to week 57
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
From baseline (week 26) to week 57
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L [54 mg/dL]), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline (week 26) to week 57
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
From baseline (week 26) to week 57
Change in Body Weight
Time Frame: Baseline (Week 26), Week 52
Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last).
Baseline (Week 26), Week 52
Relative Change in Weekly Insulin Icodec Dose
Time Frame: From week 25 to week 52
Relative change in weekly insulin icodec dose from week 25 to week 52 is presented.
From week 25 to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Actual)

April 14, 2025

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4910
  • 2022-002847-24 (EudraCT Number)
  • U1111-1281-4752 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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