Clinical trial NCT05813912: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary outcomes:
measure: Change in mean 7-point self-measured plasma glucose (SMPG) profiles
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
measure: Change in mean post-prandial glucose increment (over all meals)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
measure: Number of severe hypoglycaemic episodes (level 3)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
measure: 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)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
measure: 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)
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
measure: Change in body weight
timeFrame: From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
measure: Relative change in weekly insulin icodec dose
timeFrame: From the week prior to intensification, week 25 (visit 27) to week 52 (visit 54)
Other outcomes:
Locations:
city: Broumov
country: Czechia
facility: Edumed Broumov
city: Broumov
country: Czechia
facility: Edumed Broumov
city: Olomouc
country: Czechia
facility: Diabetologické centrum s.r.o.
city: Plzeň 3
country: Czechia
facility: DIALINE s.r.o.
city: Praha 1
country: Czechia
facility: Diabet2 s.r.o.
city: Praha 1
country: Czechia
facility: Diabet2 s.r.o.
city: Praha 4 - Chodov
country: Czechia
facility: Comfort Care Praha s.r.o.
city: Praha 4
country: Czechia
facility: Medicon a.s.
city: Praha 5
country: Czechia
facility: EUC Klinika Praha a.s.
city: Praha
country: Czechia
facility: Diabetologická a endokrinologická ambulance Praha
city: Cheras
country: Malaysia
facility: Hospital Universiti Kebangsaan Malaysia
state: Kuala Lumpur
city: Sarawak
country: Malaysia
facility: Hospital Miri
state: Miri
city: Sungai Buloh
country: Malaysia
facility: Universiti Teknologi MARA, Sungai Buloh Campus
state: Selangor
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya
state: Wilayah Persekutuan Putrajaya
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya
state: Wilayah Persekutuan Putrajaya
city: Gorzow Wielkopolski
country: Poland
facility: Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
state: Lubuskie
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Tarnow
country: Poland
facility: Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
state: Malopolskie
city: Tarnow
country: Poland
facility: Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek
state: Malopolskie
city: Warszawa
country: Poland
facility: NBR Polska
state: Mazowieckie
city: Lodz
country: Poland
facility: Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
state: Wojewodztwo Lodzkie
city: Bialystok
country: Poland
facility: Osteo-Medic s.c. A. Racewicz, J. Supronik
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House
city: Gdansk
country: Poland
facility: NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
city: Gdansk
country: Poland
facility: NZOZ Gdanska Poradnia Cukrzycowa
city: Gorzow Wielkopolski
country: Poland
facility: Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Lodz
country: Poland
facility: Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Wierzchoslawice
country: Poland
facility: Poradnia Chorob Metabolicznych w Wierzchoslawicach
city: Novi Sad
country: Serbia
facility: Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
state: Vojvodina
city: Belgrade
country: Serbia
facility: CHC Zvezdara, Clinical department for endocrinology
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital - Ped-Endo and Metabolism
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital - Ped-Endo and Metabolism
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: