A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3) (ONWARDS 3)

May 25, 2026 updated by: Novo Nordisk A/S

A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.

Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

588

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1023AAB
        • STAT Research
      • CABA, Argentina, C1060ABA
        • CEDIC Centro de Investigación Clínica
      • CABA, Argentina, C1440AAD
        • CENUDIAB Centro Médico de Nutrición v Diabetes
      • Mendoza, Argentina, 5500
        • Instituto de Clínica Médica y Diabetes
  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Innere Medizin Graz
      • Graz, Austria, 8036
        • Universitätsklinik für Innere Medizin
      • Linz, Austria, 4021
        • Barmh. Brüder Linz, Konventspital
      • Vienna, Austria, 1120
        • Ordination Dr. Günter Sokol
      • Vienna, Austria, 1130
        • Klinik Hietzing 3. Med. Abt.
      • Vienna, Austria, 1120
        • Gesundheitszentrum Hetzendorf
      • Vienna, Austria, 1140
        • Hanusch-Krankenhaus, Wien
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-040
        • Centro de Diabetes Curitiba
      • Curitiba, Paraná, Brazil, 80045-110
        • Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clinica Ltda
  • Canada
      • Québec, Canada, G1V 4G2
        • Centre Hospitalier de l'Université Laval
      • Québec, Canada, G1G 5X1
        • 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
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • BC Diabetes Canada
      • Vancouver, British Columbia, Canada, V6H 3X8
        • Dr. Ehud Ur
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic
    • 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
        • LMC ClinRsrh Inc.Brampton
      • Cambridge, Ontario, Canada, N1R 7R1
        • Saul Vizel Pro. Med. Corp
      • Concord, Ontario, Canada, L4K 4M2
        • LMC Clinical Res Thornhill
      • Etobicoke, Ontario, Canada, M9R 4E1
        • LMC Endo Ctr (Etobicoke) Ltd
      • Greater Sudbury, Ontario, Canada, P3B 4H5
        • Janik Research
      • Hamilton, Ontario, Canada, L8M 1K7
        • Premier Clinical Trial Research Network (PCTRN)
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Hospital
      • London, Ontario, Canada, N6G 2M1
        • Western Univ. Cnt for Studies in Fam Med
      • Nepean, Ontario, Canada, K2J 0V2
        • LMC Research Inc. Ottawa
      • Nepean, Ontario, Canada, K2J 4A7
        • Manna Research Ottawa
      • Oakville, Ontario, Canada, L6M 1M1
        • LMC Oakville
      • Oshawa, Ontario, Canada, L1J 2K1
        • Dr. James Cha
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clin Res Group,Inc
      • Toronto, Ontario, Canada, M3J 0K2
        • Canadian Phase Onward Inc.
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr Anil K Gupta Med Prof Corp
      • Toronto, Ontario, Canada, M4G 3E8
        • Centricity Research LMC (Toronto)
    • Quebec
      • Brossard, Quebec, Canada, J4Z 2K9
        • ViaCar Recherche Clinique Inc
      • Montreal, Quebec, Canada, H4N 2W2
        • Centre Medical Acadie
      • Montreal, Quebec, Canada, H1Y 3L1
        • Clinique de Recherche Medpharmgene Inc.
      • Saint-Laurent, Quebec, Canada, H4T 1Z9
        • LMC Clin Rsrch Inc. (Montreal)
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Q & T Research Sherbrooke Inc.
      • Victoriaville, Quebec, Canada, G6P 6P6
        • Diex Recherche Victoriaville
  • China
    • Anhui
      • Hefei, Anhui, China, 230061
        • The First Affiliated Hospital of Anhui Medical University-Endocrinology
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese People's Liberation Army General Hospital-Endocrinology
      • Beijing, Beijing Municipality, China, 101200
        • Beijing Pinggu Hospital-Endocrinology
      • Beijing, Beijing Municipality, China, 101200
        • Beijing Pinggu Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Hospital
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Cangzhou People's Hospital-Endocrinology
      • Hengshui, Hebei, China, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Nanjing, Jiangsu, China, 211199
        • Nanjing Jiangning Hospital-Endocrinology
      • Zhenjiang, Jiangsu, China, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200240
        • Shanghai Fifth People's Hospital-Endocrinology
      • Shanghai, Shanghai Municipality, China, 200072
        • Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • General Hospital of Tianjin Medical University
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital-Endocrinology
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • The Second Affiliated Hospital of Kunming Medical University
  • Czechia
      • Broumov, Czechia, 550 01
        • Edumed Broumov
      • Pardubice, Czechia, 530 02
        • Diahelp - diabetologie
      • Plzeň 3, Czechia, 301 00
        • DIALINE s.r.o.
      • Prague, Czechia, 160 00
        • FLEDIP s.r.o.
      • Prague, Czechia, 110 00
        • Diabet2 s.r.o.
      • Prague, Czechia, 150 00
        • EUC Klinika Praha a.s.
      • Prague, Czechia, 18600
        • Master Centre for Czech Rep
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital Diabetes og Hormonsygdomme
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
      • Hellerup, Denmark, 2900
        • Steno Diabetes Center Cph_Steno Diabetes Center Cph
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital Endokrinologisk forsk. afs. 159
  • France
      • Le Coudray, France, 28630
        • Les Hopitaux de Chartres-Hopital Louis Pasteur
      • Lyon, France, 69008
        • Centre Medical Medicina Rockefeller
      • Narbonne, France, 11100
        • Centre Hospitalier de Narbonne
      • Paris, France, 75877
        • Ap-Hp-Hopital Bichat-Claude Bernard
      • Paris La Défense, France, 92936
        • Master centre for France
      • Pessac, France, 33600
        • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon-Hôpital Lyon Sud
      • Saint-Herblain, France, 44800
        • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-3
      • Toulouse, France, 31054
        • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
      • Vénissieux, France, 69200
        • Centre de Recherche Clinique Portes Du Sud
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Consultorio Arechavaleta Granell María del Rosario
    • Sonora
      • Hermosillo, Sonora, Mexico, 83280
        • Investigación Médica Sonora S.C.
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research LLC
      • Manati, Puerto Rico, 00674
        • Manati Ctr For Clin Research
      • Rio Piedras, Puerto Rico, 00921
        • Luis Rivera Colon, M.D., FACDS
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital_Metabolic Dept.
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35222
        • Univ of Alabama Birmingham
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC
      • Banning, California, United States, 92220
        • Advanced Clinical Research/Rancho Paseo Medical Group
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Carmichael, California, United States, 95608
        • Med Center Medical Clinic
      • Escondido, California, United States, 92025
        • Headlands Research California, LLC
      • Fresno, California, United States, 93720
        • Valley Research
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Lancaster, California, United States, 93534
        • First Valley Medical Group
      • Lincoln, California, United States, 95648
        • Clinical Trials Research_Sacramento
      • Lomita, California, United States, 90717
        • Torrance Clin Res Inst, Inc.
      • North Hollywood, California, United States, 91606
        • Providence Clinical Research
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Palm Springs, California, United States, 92262
        • Desert Oasis Hlthcr Med Group
      • San Ramon, California, United States, 94583
        • NorCal Endocrinology and Internal Medicine
      • Tustin, California, United States, 92780
        • Diabetes Research Center
      • Ventura, California, United States, 93003
        • Coastal Metabolic Research Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Denver Endocrinology Diabetes and Thyroid Center
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Doral, Florida, United States, 33122
        • Revival Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Ctr for Clin Res
      • Jacksonville, Florida, United States, 32216
        • Est Cst Inst for Rsrch,Jksnvil
      • Miami, Florida, United States, 33136
        • University of Miami
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Orlando, Florida, United States, 32825
        • Florida Institute for Clinical Research
      • 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
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Assoc. LLC
      • Sugar Hill, Georgia, United States, 30518
        • RNA America Health Sciences
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606-2806
        • Cotton-Oneill Diabetes and End
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • St Elizabeth Physicians Heart
      • Paducah, Kentucky, United States, 42001
        • Four Rivers Clinical Research Inc
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Community Clin Res Ctr
      • Rockville, Maryland, United States, 20852
        • Endo and Metab Consultants
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus HC PLC Troy Med Res
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes & Endo Specialists Inc
    • 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 Diabete
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clin Trials, Inc.
    • New York
      • Brooklyn, New York, United States, 11215
        • N.Y. Total Medical Care PC
      • Great Neck, New York, United States, 11021
        • Northwell Health Div of Endo
      • New York, New York, United States, 10016
        • NYU Grossman School of Med
      • 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
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physician's East Endocrinology
      • Raleigh, North Carolina, United States, 27609
        • Medication Management, LLC
      • Wilmington, North Carolina, United States, 28401
        • Accellacare
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine
      • Winston-Salem, North Carolina, United States, 27103
        • Ardmore Family Practice
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diab & Endo Assoc of Stark Co
      • Dayton, Ohio, United States, 45439
        • Providence Health Partners Ctr
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group, Inc.
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source Inc
      • Perrysburg, Ohio, United States, 43551
        • Daniel G Williams MD
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University_Portland_0
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Multispeciality Group Inc
    • 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, 37421
        • WR-ClinSearch, LLC
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diab & Endo, P.A.
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Res-Dallas
      • Dallas, Texas, United States, 75390-9302
        • UT Southwestern Med Cntr
      • Houston, Texas, United States, 77024
        • Primecare Medical Group
      • Houston, Texas, United States, 77040
        • JCCT- Juno NW Houston
      • Lampasas, Texas, United States, 76550
        • Fmc Science, Llc
      • 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
      • Sugar Land, Texas, United States, 77479
        • Elite Medical Care
    • Utah
      • Bountiful, Utah, United States, 84010
        • Wade Family Medicine
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Danville, Virginia, United States, 24541
        • Spectrum Medical, Inc
      • Newport News, Virginia, United States, 23606
        • TPMG Clinical Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Clinical Investigation Specialists Inc, Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
  • HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
  • 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 anti-diabetic 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 oral anti-diabetic 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).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists

  • Body mass index (BMI) below or equal to 40.0 kg/m^2.

Exclusion Criteria:

  • Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
  • Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
  • 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once weekly insulin icodec + once daily placebo
Participants will get once daily and once weekly injections
Drug: Insulin icodec

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections

Drug: Placebo insulin degludec

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections
Experimental: Once weekly placebo and once daily insulin degludec
Participants will get once daily and once weekly injections
Drug: Placebo insulin icodec

You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections

Drug: Insulin degludec

You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (Week 0), Week 26
Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome data is evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Baseline (Week 0), Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (Week 0), Week 26
Change in FPG from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Baseline (Week 0), Week 26
Number of Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline (week 0) to week 31
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. The outcome data was evaluated based on the on-tratment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
From baseline (week 0) to week 31
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (< 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter)
Time Frame: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 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. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
From baseline (week 0) to week 31
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)
Time Frame: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L) (54 mg/dL), confirmed by blood glucose [BG] meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period.
From baseline (week 0) to week 31
Number of Severe Hypoglycaemic Episodes (Level 3)
Time Frame: From baseline (week 0) to week 26
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 26
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter)
Time Frame: From baseline (week 0) to week 26
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 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 26
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)
Time Frame: From baseline (week 0) to week 26
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) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) confirmed by blood glucose (BG) meter.
From baseline (week 0) to week 26
Change in Body Weight
Time Frame: Baseline (Week 0), Week 26
Change in body weight from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Baseline (Week 0), Week 26
Mean Weekly Insulin Dose
Time Frame: From week 24 to week 26
Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
From week 24 to week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

June 23, 2022

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4479
  • U1111-1247-5218 (Other Identifier: World Health Organization (WHO))
  • 2020-000472-37 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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