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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813912
• Other study ID #: NN1436-4910
• Secondary ID: 2022-002847-24U1
• Status: Recruiting
• Phase: Phase 3
• Start date: September 22, 2023
• Est. completion date: July 25, 2025

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: July 25, 2025
• Est. primary completion date: September 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Icodec
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
• Semaglutide
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.

Locations

Country	Name	City	State
Czechia	Edumed Broumov	Broumov
Czechia	Diabetologické centrum s.r.o.	Olomouc
Czechia	DIALINE s.r.o.	Plzen 3
Czechia	Diabetologická a endokrinologická ambulance Praha	Praha
Czechia	Diabet2 s.r.o.	Praha 1
Czechia	Medicon a.s.	Praha 4
Czechia	Comfort Care Praha s.r.o.	Praha 4 - Chodov
Czechia	EUC Klinika Praha a.s.	Praha 5
Malaysia	Hospital Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur
Malaysia	Hospital Putrajaya	Putrajaya	Wilayah Persekutuan Putrajaya
Malaysia	Hospital Miri	Sarawak	Miri
Malaysia	Universiti Teknologi MARA, Sungai Buloh Campus	Sungai Buloh	Selangor
Poland	Osteo-Medic s.c. A. Racewicz, J. Supronik	Bialystok
Poland	Centrum Badan Klinicznych PI-House	Gdansk
Poland	NZOZ Gdanska Poradnia Cukrzycowa	Gdansk
Poland	NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.	Gdansk
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski	Lubuskie
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET	Krakow	Malopolskie
Poland	Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia	Lodz
Poland	Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek	Tarnow	Malopolskie
Poland	NBR Polska	Warszawa	Mazowieckie
Poland	NBR Polska Tomasz Klodawski	Warszawa
Poland	Poradnia Chorob Metabolicznych w Wierzchoslawicach	Wierzchoslawice
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Clinical Hospital Centre Zemun	Belgrade
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr	Kragujevac
Serbia	Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.	Novi Sad	Vojvodina
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Ramathibodi Hospital - Ped-Endo and Metabolism	Bangkok
Thailand	Ramathibodi Hospital - Ped-Endo and Metabolism	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czechia,  Malaysia,  Poland,  Serbia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mean 7-point self-measured plasma glucose (SMPG) profiles	Measured in millimoles per liter (mmol/L).	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary	Change in mean post-prandial glucose increment (over all meals)	Measured in mmol/L.	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary	Change in fasting plasma glucose (FPG)	Measured in mmol/L.	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary	Number of severe hypoglycaemic episodes (level 3)	Measured in number of episodes.	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Secondary	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)	Measured in number of episodes.	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Secondary	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)	Measured as number of episodes.	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Secondary	Change in body weight	Measured in kilograms (Kg).	From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary	Relative change in weekly insulin icodec dose	Measured in units (U).	From the week prior to intensification, week 25 (visit 27) to week 52 (visit 54)