NCT05813912CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- First submitted
- 3 Apr 2023
- Start date
- 22 Sept 2023
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05813912
- EU CT number
- 2022-502717-28-00
- EudraCT number
- 2022-002847-24
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 148
- From 22 Sept 2023 to the primary completion date, 14 Apr 2025
- 28 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
Other
- Planned coronary, carotid or peripheral artery revascularization
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edumed s.r.o. Coordinator of this site? Confirm its status | Broumov | Czechia | Completed |
| DIALINE s.r.o. Coordinator of this site? Confirm its status | Plzeň 3 | Czechia | Completed |
| Comfort Care a.s. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Diabet2 s.r.o. Coordinator of this site? Confirm its status | Prague 1 | Czechia | Completed |
| Institute For Clinical And Experimental Medicine Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| MEDICON a.s. Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| EUC Klinika Praha a.s. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Completed |
| Hospital Canselor Tuanku Muhriz UKM Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
| Hospital Miri Coordinator of this site? Confirm its status | Miri | Malaysia | Unknown status |
| Hospital Putrajaya Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Hospital Seri Manjung Coordinator of this site? Confirm its status | Seri Manjung | Malaysia | Unknown status |
| Universiti Teknologi MARA, Sungai Buloh Campus Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Gdanska Poradnia Cukrzycowa Sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski Coordinator of this site? Confirm its status | Gorzów Wielkopolski | Poland | Completed |
| Centrum Medyczne Pratia Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek Coordinator of this site? Confirm its status | Tarnów | Poland | Completed |
| Nbr Polska Tomasz Klodawski Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| CHC Zvezdara, Clinical department for endocrinology Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Hospital Centre Zemun Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis. Coordinator of this site? Confirm its status | Novi Sad | Serbia | Unknown status |
| Ramathibodi Hospital - Ped-Endo and Metabolism Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.