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

Last updated: May 6, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Semaglutide

Insulin Icodec

Clinical Study ID

NCT05813912
NN1436-4910
U1111-1281-4752
2022-002847-24
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days prior tothe 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 internationalunits per kilograms per day (IU/kg/day) or 20 IU/day) without concomitantglucagon-like peptide-1 receptor agonists (GLP-1 RA) >= 90 days prior to the day ofscreening with or without any of the following antidiabetic drugs/regimens with stabledoses >= 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 combinationproducts (for the allowed individual oral anti-diabetic drugs)

Exclusion

Exclusion Criteria:

  • Presence or history of pancreatitis (acute or chronic) within 180 days beforescreening
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris ortransient ischaemic attack within 180 days prior to the day of screening and betweenscreening and initiation
  • Chronic heart failure classified as being in New York Heart Association (NYHA) ClassIV at screening
  • Planned coronary, carotid or peripheral artery revascularization
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified bya fundus examination performed within the past 90 days prior to screening or in theperiod between screening and initiation. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified for non-dilatedexamination

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
September 22, 2023
Estimated Completion Date:
July 25, 2025

Connect with a study center

  • Edumed Broumov

    Broumov, 550 01
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Broumov, 550 01
    Czechia

    Site Not Available

  • Diabetologické centrum s.r.o.

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Plzeň, 301 00
    Czechia

    Site Not Available

  • DIALINE s.r.o.

    Plzeň 3, 301 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Plzeň 3, 301 00
    Czechia

    Site Not Available

  • Diabetologická a endokrinologická ambulance Praha

    Praha, 140 21
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha, 140 21
    Czechia

    Site Not Available

  • Diabet2 s.r.o.

    Praha 1, 110 00
    Czechia

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Praha 1, 110 00
    Czechia

    Site Not Available

  • Medicon a.s.

    Praha 4, 140 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4, 140 00
    Czechia

    Site Not Available

  • Comfort Care Praha s.r.o.

    Praha 4 - Chodov, 148 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 4 - Chodov, 148 00
    Czechia

    Site Not Available

  • EUC Klinika Praha a.s.

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Hospital Universiti Kebangsaan Malaysia

    Cheras, Kuala Lumpur 56000
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Cheras, Kuala Lumpur 56000
    Malaysia

    Active - Recruiting

  • Hospital Miri

    Sarawak, Miri 98000
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Sarawak, Miri 98000
    Malaysia

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Sungai Buloh, Selangor 47000
    Malaysia

    Site Not Available

  • Universiti Teknologi MARA, Sungai Buloh Campus

    Sungai Buloh, Selangor 47000
    Malaysia

    Site Not Available

  • Hospital Putrajaya

    Putrajaya, Wilayah Persekutuan Putrajaya 62250
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Putrajaya, Wilayah Persekutuan Putrajaya 62250
    Malaysia

    Active - Recruiting

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzow Wielkopolski, Lubuskie 66-400
    Poland

    Site Not Available

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

    Krakow, Malopolskie 31-261
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Krakow, Malopolskie 31-261
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Tarnow, Malopolskie 33-100
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek

    Tarnow, Malopolskie 33-100
    Poland

    Site Not Available

  • NBR Polska

    Warszawa, Mazowieckie 00-710
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, Mazowieckie 00-710
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, 15-351
    Poland

    Site Not Available

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

    Bialystok, 15-351
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House

    Gdansk, 80-546
    Poland

    Site Not Available

  • NZOZ Gdanska Poradnia Cukrzycowa

    Gdansk, 80-858
    Poland

    Site Not Available

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-858
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gorzow Wielkopolski, 66-400
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Katowice, 40-081
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, 90-302
    Poland

    Site Not Available

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

    Lodz, 90-302
    Poland

    Active - Recruiting

  • NBR Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Wierzchoslawice, 33-122
    Poland

    Site Not Available

  • Poradnia Chorob Metabolicznych w Wierzchoslawicach

    Wierzchoslawice, 33-122
    Poland

    Site Not Available

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

    Novi Sad, Vojvodina 21000
    Serbia

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Novi Sad, Vojvodina 21000
    Serbia

    Active - Recruiting

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Centre Zemun

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kragujevac, 34000
    Serbia

    Active - Recruiting

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330
    Thailand

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • Rajavithi Hospital

    Bangkok, 10400
    Thailand

    Site Not Available

  • Ramathibodi Hospital - Ped-Endo and Metabolism

    Bangkok, 10400
    Thailand

    Site Not Available

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