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

NCT05813912 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN1436-49102022-002847-24U1111-1281-4752
• Study Type: interventional
• Target: 148
• Locations: 5 countries
• Sites: 39

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

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured in percentage (%) points.

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

Secondary Outcomes (8)

• Change in mean 7-point self-measured plasma glucose (SMPG) profiles

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

• Change in mean post-prandial glucose increment (over all meals)

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

• Change in fasting plasma glucose (FPG)

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)

• Number of severe hypoglycaemic episodes (level 3)

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)

• 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)

  From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)

Study Arms (1)

Insulin Icodec + Semaglutide

EXPERIMENTAL

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; Drug: Semaglutide

Interventions

Insulin Icodec DRUG

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

Insulin Icodec + Semaglutide

Semaglutide DRUG

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

Insulin Icodec + Semaglutide

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (39)

Edumed Broumov

Broumov, 550 01, Czechia

Location

DIAMIN

Chrudim, 537 01, Czechia

Location

Diabetologické centrum s.r.o.

Olomouc, 779 00, Czechia

Location

DIALINE s.r.o.

Plzeň 3, 301 00, Czechia

Location

Diabet2 s.r.o.

Prague, 110 00, Czechia

Location

Medicon a.s.

Prague, 140 00, Czechia

Location

Diabetologická a endokrinologická ambulance Praha

Prague, 140 21, Czechia

Location

EUC Klinika Praha a.s.

Prague, 150 00, Czechia

Location

Comfort Care Praha s.r.o.

Praha 4 - Chodov, 148 00, Czechia

Location

DiaPodi care s.r.o.

Soběslav I, 39201, Czechia

Location

Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, Perak, 32040, Malaysia

Location

Hospital Putrajaya

Putrajaya, Putrajaya, 62250, Malaysia

Location

Hospital Miri

Miri, Sarawak, 98000, Malaysia

Location

Universiti Teknologi MARA, Sungai Buloh Campus

Sungai Buloh, Selangor, 47000, Malaysia

Location

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

Krakow, Lesser Poland Voivodeship, 31-261, Poland

Location

Metabolica Sp. z o.o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

NBR Polska

Warsaw, Masovian Voivodeship, 00-710, Poland

Location

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

Bialystok, 15-351, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

Location

NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

Gdansk, 80-858, Poland

Location

NZOZ Gdanska Poradnia Cukrzycowa

Gdansk, 80-858, Poland

Location

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

Gorzów Wielkopolski, 66-400, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

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

Lodz, 90-302, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Poradnia Chorob Metabolicznych w Wierzchoslawicach

Wierzchosławice, 33-122, Poland

Location

Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu

Zabrze, 41-800, Poland

Location

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

Lodz, Łódź Voivodeship, 90-302, Poland

Location

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

Novi Sad, Vojvodina, 21000, Serbia

Location

CHC Zvezdara, Clinical department for endocrinology

Belgrade, 11000, Serbia

Location

Clinical Hospital Centre Zemun

Belgrade, 11080, Serbia

Location

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

Kragujevac, 34000, Serbia

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Rajavithi Hospital_Diabetes and Endocrinology

Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital - Ped-Endo and Metabolism

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec; semaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: September 22, 2023
• Primary Completion: April 14, 2025
• Study Completion: May 16, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (4); PL (16); CZ (10); TH (4); MY (5)