A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 5)

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin icodec; Drug: Insulin Glargine 100U/mL; Drug: Insulin Degludec; Drug: Insulin Glargine 300U/mL

• Study Type: Interventional
• Enrollment (Actual): 1085
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4T3
    • Diex Recherche Quebec Inc.
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Québec, Canada, G1G 3Y8
    • Recherche Clinique Sigma inc
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • LMC Clin Res Inc. Calgary
    • Red Deer, Alberta, Canada, T4N 6V7
      • The Bailey Clinic
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 4A1
      • Dr. M.B. Jones Inc
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Rivergrove Medical Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Commonwealth Medical Clinic
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Health Authority
  • Ontario
    • Barrie, Ontario, Canada, L4N 7L3
      • LMC Diabetes & Endocrinology (Barrie)
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research LMC
    • Concord, Ontario, Canada, L4K 4M2
      • LMC Clinical Res Thornhill
    • Courtice, Ontario, Canada, L1E2J5
      • Medical Trust Clinics, Inc.
    • Etobicoke, Ontario, Canada, M9R 4E1
      • LMC Endo Ctr (Etobicoke) Ltd
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Med Clin Trials
    • Hamilton, Ontario, Canada, L8M 1K7
      • Premier Clinical Trial Research Network (PCTRN)
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
    • London, Ontario, Canada, N6G 2M1
      • Western Univ. Cnt for Studies in Fam Med
    • Nepean, Ontario, Canada, K2J 0V2
      • LMC Research Inc. Ottawa
    • Oakville, Ontario, Canada, L6M 1M1
      • LMC Oakville
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clin Res Group,Inc
    • Stoney Creek, Ontario, Canada, L8J 0B6
      • Winterberry Family Medicine
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K Gupta Medicine Professional Corporation
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Endo Centres Ltd.(Bayview)
  • Quebec
    • Brossard, Quebec, Canada, J4Z 2K9
      • ViaCar Recherche Clinique Inc
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Laval, Quebec, Canada, H7T 2P5
      • Ctr de rech Clin de Laval
    • Mirabel, Quebec, Canada, J7J 2K8
      • Manna Research Mirabel
    • Montreal, Quebec, Canada, H4A 3T2
      • Applied Med Inf Res
    • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
      • Diex Recherche Joliette
    • Saint-Laurent, Quebec, Canada, H4T 1Z9
      • LMC Clin Rsrch Inc. (Montreal)
    • Saint-Marc-des-Carrieres, Quebec, Canada, G0A 4B0
      • Ctr Méd. et pro d l'Ost d port
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriaville
• Germany
  • Bad Mergentheim, Germany, 97980
    • Diabetespraxis Mergentheim
  • Berlin, Germany, 13597
    • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
  • Essen, Germany, 45136
    • InnoDiab Forschung GmbH
  • Falkensee, Germany, 14612
    • Zentrum für klinische Forschung, Dr. med. Lüdemann
  • Hamburg, Germany, 22607
    • Wendisch/Dahl Hamburg (DZHW)
  • Hohenmölsen, Germany, 06679
    • Milek, Hohenmölsen
  • Münster, Germany, 48145
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Münster, Germany, 48153
    • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
  • Oldenburg in Holstein, Germany, 23758
    • RED-Institut für medizinische Forschung und Fortbildung GmbH
  • Rehlingen-Siersburg, Germany, 66780
    • Praxis Dr. med. Wenzl-Bauer
  • Riesa, Germany, 01587
    • Med.Versorgungszentrum Riesa-Dr. Bieler
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Zentrum für klinische Studien Alexander Segner
  • Stuttgart, Germany, 70378
    • MZM Praxis Drs. Erlinger
  • Wangen, Germany, 88239
    • Zentrum für klinische Studien Allgäu Oberschwaben
• Greece
  • Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, 115 25
    • Iatriko Psychicou Private Clinic
  • Athens, Greece, GR-11526
    • Korgiallenio - Benakio Hospital (Red Cross Hosp.)
  • Athens, Greece, 17562
    • Iatriko Athinon 'Palaiou Falirou'
  • Athens, Greece, 115 27
    • 'G. Gennimatas' General Hospital of Athens
  • Larissa, Greece, 41110
    • Univ Gen Hospital Larisa
  • Thessaloniki, Greece, 54636
    • AHEPA General University Hospital
  • Thessaloniki, Greece, GR-54642
    • "Ippokrateio" General Hosp Thessaloniki, A' Internal Med
  • Thessaloniki, Greece, 57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 54642
    • "Ippokrateio" G.H. of Thessaloniki
  • Thessaloniki, Greece, 54635
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Thessaloniki, Greece, 54645
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
• Hungary
  • Budapest, Hungary, 1032
    • Szent Margit Kórház
  • Budapest, Hungary, 1036
    • Óbudai Egészségügyi Centrum
  • Budapest, Hungary, 1042
    • Szőcs Depot Egészségügyi Szolgáltató Kft.
  • Budapest, Hungary, 1089
    • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Budapest, Hungary, 1132
    • MED-TIMA Kft.
  • Budapest, Hungary, 1134
    • Mh Egészségügyi Központ
  • Budapest, Hungary, 1152
    • Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft.
  • Kaposvár, Hungary, 7400
    • Kaposi Mór Oktató Kórház
  • Szeged, Hungary, H-6725
    • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
  • Szombathely, Hungary, 9700
    • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Korhaz
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4025
      • Belinus Bt.
  • Komárom-Esztergom
    • Komárom, Komárom-Esztergom, Hungary, 2900
      • Komaromi Selye Janos Korhaz
• Poland
  • Gdansk, Poland, 80-858
    • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Lodz, Poland, 90-132
    • Gabinet Lekarski Malgorzata Saryusz-Wolska
  • Lodz, Poland, 91-473
    • Pro Salus Centrum Medyczne
  • Lublin, Poland, 20-081
    • Katedra i Klinika Chorob Wewnetrznych AM w Lublinie
  • Poznan, Poland, 60-834
    • Oddzial Chorób - Wewn.
  • Puławy, Poland, 24-100
    • Velocity Nova Sp. z o.o.
  • Zabrze, Poland, 41-800
    • Poradnia dla Chorych na Cukrzycę
  • Świdnik, Poland, 21-040
    • Lubelskie Centrum Diagnostyczne Tomasz Blicharski
  • Pomeranian Voivodeship
    • Gdynia, Pomeranian Voivodeship, Poland, 81-338
      • Centrum Medyczne Pratia Gdynia
  • Świętokrzyskie Voivodeship
    • Staszów, Świętokrzyskie Voivodeship, Poland, 28-200
      • Velocity Nova Sp. z o.o.
• Puerto Rico
  • Manatí, Puerto Rico, 00674
    • Manati Ctr For Clin Research
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01000
    • T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
  • Adana, Turkey (Türkiye), 01250
    • Baskent Universitesi Adana
  • Ankara, Turkey (Türkiye), 06100
    • Ankara Universitesi Ibni Sina Hastanesi
  • Gaziantep, Turkey (Türkiye), 27070
    • Gaziantep Universitesi Tip Fakultesi Hastanesi
  • Hatay, Turkey (Türkiye), 31060
    • Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
  • Istanbul, Turkey (Türkiye), 34303
    • Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey (Türkiye), 34371
    • Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey (Türkiye), 34390
    • Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
  • Istanbul, Turkey (Türkiye), 34718
    • Haydarpasa Numune Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Istanbul, Turkey (Türkiye), 34760
    • Umraniye Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey (Türkiye), 34899
    • T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul University Medical Faculty
  • Kayseri, Turkey (Türkiye), 38039
    • Erciyes Universitesi Tip Fakultesi
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ of Alabama Birmingham
    • Guntersville, Alabama, United States, 35976
      • Lakeview Clinical Research, LLC
  • California
    • Buena Park, California, United States, 90620
      • American Clinical Trials
    • Canoga Park, California, United States, 91304
      • San Fernando Valley Hlth Inst, LLC
    • Fresno, California, United States, 93720
      • Valley Research
    • Hawthorne, California, United States, 90250
      • Advanced Investigative Medicine, Inc.
    • Huntington Beach, California, United States, 92648
      • Diabetes/Lipid Mgmt & Res Ctr
    • La Jolla, California, United States, 92037
      • Scripps Whittier Diabetes Inst
    • Lancaster, California, United States, 93534
      • First Valley Medical Group
    • Lomita, California, United States, 90717
      • Torrance Clin Res Inst, Inc.
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Palm Springs, California, United States, 92262
      • Desert Oasis Hlthcr Med Group
    • Sacramento, California, United States, 95821
      • Clinical Trials Research_Sacramento
    • San Diego, California, United States, 92111
      • San Diego Family Care
    • San Ramon, California, United States, 94583
      • NorCal Endocrinology and Internal Medicine
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research_Spring Valley
    • Ventura, California, United States, 93003
      • Coastal Metabolic Research Center
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Est Cst Inst for Rsrch,Jksnvil
    • Mt. Dora, Florida, United States, 32757
      • Adult Medicine of Lake County, Inc.
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clin Res Port Richey
    • Orlando, Florida, United States, 32825
      • Florida Inst For Clin Res
    • Palm Harbor, Florida, United States, 34684
      • Suncoast Clinical Research, Inc.
    • Palm Harbor, Florida, United States, 34684-3609
      • Palm Harbor Medical Associates
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute Inc
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Cent FL
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30076
      • Endo Res Solutions, Inc
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
    • Springfield, Illinois, United States, 62711
      • Central Illinois Diabetes and Clinical Research
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Diab & Endo Ctr
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Community Clin Res Ctr
    • Rockville, Maryland, United States, 20852
      • Endo and Metab Consultants
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Northern Pines Hlth Ctr, PC
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare, PLC.
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Jefferson City Medical Group, PC
  • Nebraska
    • Omaha, Nebraska, United States, 68198-3020
      • Univ of Nebraska Medical CTR
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clin
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center Inc-Vegas
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Southern New Hampshire Diabetes and Endocrinology
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clin Trials, Inc.
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
    • Brooklyn, New York, United States, 11215
      • N.Y. Total Medical Care PC
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research, PLLC
    • Smithtown, New York, United States, 11787
      • Endocrine Associates of Long Island, PC
    • West Seneca, New York, United States, 14224
      • Southgate Medical Group, LLP
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physicians East Endocrinology
    • Raleigh, North Carolina, United States, 27609
      • Medication Management, LLC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC_Fargo
  • Ohio
    • Canton, Ohio, United States, 44718
      • Diab & Endo Assoc of Stark Co
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners Ctr
    • Wadsworth, Ohio, United States, 44281
      • New Venture Medical Research
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • The Diabetes Center, LLC
    • Simpsonville, South Carolina, United States, 29681-1538
      • Hillcrest Clinical Research
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research, LLC
    • Chattanooga, Tennessee, United States, 37411
      • Univ Diab & Endo Consultants
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Morristown, Tennessee, United States, 37813
      • HealthStar Physicians PC
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Med Spec LLP
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology
    • Austin, Texas, United States, 78731
      • Texas Diab & Endo, P.A.
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Dallas, Texas, United States, 75390-9302
      • UT Southwestern Med Cntr
    • Houston, Texas, United States, 77074
      • Juno Research, LLC
    • Houston, Texas, United States, 77024
      • PrimeCare Medical Group
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • Katy, Texas, United States, 77450
      • Medical Colleagues-Texas LLP
    • Lampasas, Texas, United States, 76550
      • Fmc Science, Llc
    • Laredo, Texas, United States, 78041
      • Andres Garcia-Zuniga, MD, P.A
    • Round Rock, Texas, United States, 78681
      • Texas Diab & Endo, P.A.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC
    • San Antonio, Texas, United States, 78233
      • NE Clin Res of San Antonio
    • Sugar Land, Texas, United States, 77478
      • Simcare Medical Research, LLC
  • Utah
    • Bountiful, Utah, United States, 84010
      • Wade Family Medicine
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
  • Virginia
    • Newport News, Virginia, United States, 23606
      • TPMG Clinical Research
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Inv Spec, Inc.Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
• HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
• Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
• Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists.
• Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products.
• Previous participation in this trial. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
• Any disorder which in the investigator's opinion might jeopardise subject's safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin icodec with DoseGuide; Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.	Drug: Insulin icodec; Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Active Comparator: Once daily basal insulin analogues; Participants randomised to basal insulin analogue injections once daily	Drug: Insulin Glargine 100U/mL; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.; Drug: Insulin Degludec; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.; Drug: Insulin Glargine 300U/mL; Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Change in HbA1c from baseline (week 0) to week 52 is presented.	Baseline (week 0), week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Baseline to Treatment Discontinuation or Intensification	Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.	From baseline (week 0) to week 52
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction	Change in DTSQs in total treatment satisfaction is presented. The DTSQs questionnaire was used to assess participants treatment satisfaction which contained 8 components (DTSQs Item 1-8 : how satisfied are you with your current treatment, how often have you felt that blood sugars have been unacceptably high, how often have you felt that blood sugars have been unacceptably low, how convenient have you been finding your treatment to be recently, how flexible have you been finding your treatment to be recently, how satisfied are you with your understanding of your diabetes, would you recommend treatment to someone else with your kind of diabetes, how satisfied would you be to continue with present form of treatment). The result presented is the treatment satisfaction summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Total scores for treatment satisfaction range from 0-36 with 0 being the lowest and 36 being the highest score in total treatment satisfaction.	Baseline (week 0), week 52
Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain	Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance domain at week 52 is presented. The TRIM-D questionnaire was developed to capture the impact of diabetes treatment on patients' functioning and well-being. The questionnaire was used to measure the compliance between the treatment groups. The total TRIM-D compliance score is computed by summing across the items and then transforming to a 0-100 scale with higher score indicating better compliance.	At end of treatment (week 52)
Number of Severe Hypoglycaemic Episodes (Level 3)	Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.	From baseline (week 0) to week 57
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 Millimoles Per Liter [mmol/L] (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter)	Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 millimoles per liter [mmol/L] (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.	From baseline (week 0) to week 57
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)	Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.	From baseline (week 0) to week 57

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.
• Riddell MC, Heller S, Carstensen L, Rocha TMP, Kehlet Watt S, Woo VC. The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5. Diabetologia. 2025 Jul;68(7):1416-1422. doi: 10.1007/s00125-025-06414-6. Epub 2025 Apr 5.
• Billings LK, Asong M, Bog M, Clancy S, Kruse C, de Laguiche E, Maddaloni E. AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes. Diabetes Ther. 2025 Feb;16(2):227-239. doi: 10.1007/s13300-024-01679-3. Epub 2024 Dec 19.
• Polonsky W, Benamar M, Carstensen L, Davies M, Meller Donatsky A, Franek E, Kellerer M, Philis-Tsimikas A, Goldenberg R. Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin in individuals with type 2 diabetes: An analysis of patient-reported outcomes and participant interviews from ONWARDS 2 and 5 and a physician survey from ONWARDS 1. Diabetes Res Clin Pract. 2024 Nov;217:111885. doi: 10.1016/j.diabres.2024.111885. Epub 2024 Oct 4.
• Bajaj HS, Aberle J, Davies M, Donatsky AM, Frederiksen M, Yavuz DG, Gowda A, Lingvay I, Bode B. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Ann Intern Med. 2023 Nov;176(11):1476-1485. doi: 10.7326/M23-1288. Epub 2023 Sep 26.
• Philis-Tsimikas A, Krogsdahl Bache J, Fu A, Kellerer M, Salvesen-Sykes K, Bain SC. Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec. Diabetes Ther. 2025 Aug;16(8):1615-1631. doi: 10.1007/s13300-025-01745-4. Epub 2025 Jun 4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin Glargine; insulin icodec; insulin degludec
• Other Study ID Numbers: NN1436-4481; U1111-1247-5279 (Other Identifier: World Health Organization (WHO)); 2020-000476-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No