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

NCT ID: NCT05813912

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2025-05-16

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin Icodec

Intervention Type: DRUG

Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.

Semaglutide

Intervention Type: DRUG

Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.

Interventions

Insulin Icodec

Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.

Intervention Type: DRUG

Semaglutide

Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Edumed Broumov

Broumov, , Czechia

DIALINE s.r.o.

Plzeň 3, , Czechia

Diabet2 s.r.o.

Prague, , Czechia

Diabetologická a endokrinologická ambulance Praha

Prague, , Czechia

EUC Klinika Praha a.s.

Prague, , Czechia

Comfort Care Praha s.r.o.

Praha 4 - Chodov, , Czechia

Hospital Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Hospital Putrajaya

Putrajaya, Putrajaya, Malaysia

Hospital Miri

Miri, Sarawak, Malaysia

Universiti Teknologi MARA, Sungai Buloh Campus

Sungai Buloh, Selangor, Malaysia

Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, Poland

Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek

Tarnów, Lesser Poland Voivodeship, Poland

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

Gorzów Wielkopolski, Lubusz Voivodeship, Poland

NBR Polska

Warsaw, Masovian Voivodeship, Poland

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, , Poland

NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

Gdansk, , Poland

NZOZ Gdanska Poradnia Cukrzycowa

Gdansk, , Poland

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

Gorzów Wielkopolski, , Poland

Centrum Medyczne Pratia Katowice

Katowice, , Poland

Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

NBR Polska Tomasz Klodawski

Warsaw, , Poland

Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, Łódź Voivodeship, Poland

Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

Novi Sad, Vojvodina, Serbia

CHC Zvezdara, Clinical department for endocrinology

Belgrade, , Serbia

Clinical Hospital Centre Zemun

Belgrade, , Serbia

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

Kragujevac, , Serbia

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Rajavithi Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Countries

Czechia; Malaysia; Poland; Serbia; Thailand

Other Identifiers

2022-002847-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1281-4752

Identifier Type: OTHER

Identifier Source: secondary_id

NN1436-4910

Identifier Type: -

Identifier Source: org_study_id