A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 1)

November 27, 2025 updated by: Novo Nordisk A/S

A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (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 glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). 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)

984

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

  • Croatia
      • Karlovac, Croatia, 47000
        • Opca bolnica Karlovac
      • Rijeka, Croatia, 51000
        • KBC Rijeka, Endokrinologija
      • Varaždin, Croatia, 42 000
        • Opca bolnica Varazdin_Endocrinology
    • County of Osijek-Baranja
      • Osijek, County of Osijek-Baranja, Croatia, 31000
        • Poliklinika SLAVONIJA OSIJEK
  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIMS Rohtak
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth GS medical college and KEM Hospital
      • Mumbai, Maharashtra, India, 400008
        • BYL Nair Hospital and T N Medical College Department of endo
      • Pune, Maharashtra, India, 411021
        • chelleram Diabetes Institute
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • All India Institute of Medical Sciences
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Hospital, Vellore
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Osmania General Hospital
      • Hyderabad, Telangana, India, 500072
        • Ramdev Rao Hospital
      • Hyderabad, Telangana, India, 500003
        • Gandhi Hospital & Medical college
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • SSKM
  • Israel
      • Beersheba, Israel, 84101
        • Soroka MC - Outpatient Diabetes Clinic
      • Holon, Israel, 58100
        • Wolfson MC - Diabetes Clinic
      • Jerusalem, Israel, 91120
        • Hadassah Ein Karam MC - Diabetes Unit
      • Kfar Saba, Israel, 44281
        • Diabetes Clinic Meir MC
      • Petah Tikva, Israel, 49100
        • Rabin MC Beilinson - Department of Cardiothoracic Surgery
      • Rehovot, Israel, 76100
        • Kaplan MC - Metabolic Unit
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Catanzaro, Italy, 88100
        • Policlinico Mater Domini Università di Catanzaro
      • Milan, Italy, 20122
        • Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
      • Palermo, Italy, 90127
        • Policlinico Universitario Paolo Giaccone
    • RM
      • Roma, RM, Italy, 00161
        • Policlinico Umberto I Seconda Clinica Medica
  • Japan
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital, Diabetes and Metabolic
      • Chiba, Japan, 261-0004
        • Tokuyama clinic_Diabetic internal medicine
      • Fukuoka-shi, Fukuoka, Japan, 819-0006
        • Futata Tetsuhiro Clinic Meinohama_Internal medicine
      • Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic_Internal medicine
      • Kitakyusyu-shi, Fukuoka, Japan, 800-0222
        • Sugimoto Clinic,Internal Medicine
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital, Endocrinology and Metabolism
      • Miyagi, Japan, 983-0039
        • Shinden Higashi Clinic_Miyagi
      • Osaka, Japan, 569-1045
        • Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
      • Saitama, Japan, 336-0967
        • Shimizu Clinic Fusa
      • Shimotsuke-shi, Tochigi, Japan, 329-0433
        • Wakakusa Clinic
      • Tochigi, Japan, 323-0022
        • Oyama East Clinic_Internal Medicine
      • Ushiku-shi, Ibaraki, Japan, 300-1207
        • Noritake Clinic
    • Kanagawa, Japan
      • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
      • Chigasaki-shi, Kanagawa, Kanagawa, Japan, Japan, 253-0044
        • Hayashi Diabetes Clinic
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 880-0034
        • Heiwadai Hospital_Internal Medicine
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • InstitutoJalisciense de Investigación en Diabetes y Obesidad
    • México, D.F.
      • Mexico City, México, D.F., Mexico, 06700
        • Clínica Omega Diabetes, S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González_Monterrey
    • Sonora
      • Hermosillo, Sonora, Mexico, 83280
        • Investigación Médica Sonora S.C.
  • Poland
      • Radom, Poland, 26-600
        • Centrum Medyczne "Diabetika"
      • Wierzchosławice, Poland, 33-122
        • Centrum Zdrowia Tuchow Sp z o.o.
      • Zabrze, Poland, 41-800
        • Prywatny Gabinet Janusz Gumprecht
    • Lubelski
      • Lublin, Lubelski, Poland, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-044
        • NZOZ "CenterMed Lublin" Sp. z o.o.
    • Lubusz Voivodeship
      • Gorzów Wielkopolski, Lubusz Voivodeship, Poland, 66-400
        • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-710
        • NBR Polska Tomasz Klodawski
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research LLC
      • Manatí, Puerto Rico, 00674
        • Manati Ctr For Clin Research
      • San Juan, Puerto Rico, 00921
        • Consultorio Medico
  • Russia
      • Kemerovo, Russia, 650066
        • SAHI Kuzbass Hospital(former Regional clinical hospital)
      • Moscow, Russia, 119435
        • Setchenov First Moscow State Medical University
      • Moscow, Russia, 117292
        • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
      • Novosibirsk, Russia, 630099
        • Limited Law Company "Healthy Family" Medicine Center"
      • Novosibirsk, Russia, 630117
        • Scientifc Institute of Clinical and Experimental Lymphology
      • Penza, Russia, 440052
        • Penza Regional Clinical Hospital named after N.N. Burdenko
      • Saint Petersburg, Russia, 194291
        • Leningrad Regional Clinical Hospital
      • Saint Petersburg, Russia, 197110
        • Consultative & Diagnostic Center with a Outpatient Hospital
      • Saint Petersburg, Russia, 194356
        • Medinet LLC
      • Saint Petersburg, Russia, 194156
        • Limited Liability Company "Energiya Zdoroviya"
      • Saratov, Russia, 410039
        • Regional clinical cardiology dispensary
      • Tomsk, Russia, 634050
        • Siberian State Medical University
      • Voronezh, Russia, 394018
        • Voronezh Regional Clinical Consultive-diagnostic Centre
      • Yoshkar-Ola, Russia, 424004
        • Polyclinic #2 in Yoshkar-Ola
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • MEDISPEKTRUM s.r.o.
      • Bratislava, Slovakia, 84102
        • Diacrin s. r. o.
      • Bratislava, Slovakia, 821 02
        • Amb. diabetologie a poruch latkovej premeny a vyzivy
      • Malacky, Slovakia, 901 01
        • MediVet s.r.o.
      • Malacky, Slovakia, 901 01
        • SIN AZUCAR s.r.o.
      • Moldava nad Bodvou, Slovakia, 045 01
        • Diabetologicka ambulancia SchronerMED, s.r.o.
      • Trebišov, Slovakia, 07501
        • ARETEUS s.r.o.
    • Slovak Republic
      • Šahy, Slovak Republic, Slovakia, 93601
        • Peter Farkas MD, s.r.o.
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • La Roca Del Vallés, Spain, 08430
        • ABS La Roca del Vallés_Endocrinología
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28020
        • Centro de Especialidades José Marva
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Universitario Quirónsalud Madrid
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quirón
  • United Kingdom
      • Blackpool, United Kingdom, FY3 7EN
        • Layton Medical Centre
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • The Health Centre
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital_Cambridge
      • Chester, United Kingdom, CH2 1UL
        • Countess of Chester Hospital
      • Dorset, United Kingdom, BH16 5PW
        • The Adam Practice
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • High Wycombe, United Kingdom, HP11 2TT
        • Wycombe General Hospital
      • Hinckley, United Kingdom, LE10 2SE
        • Burbage Surgery
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital_Portsmouth
      • Soham, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
      • Swansea, United Kingdom, SA2 8PP
        • Joint Clinical Research Facility - Swansea
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital (Treliske)
      • Wellingborough, United Kingdom, NN8 4RW
        • Albany House Medical Centre
    • Cheshire
      • Bollington, Cheshire, United Kingdom, SK10 5JH
        • Bollington Medical Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Uni of Alabama at 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
      • Banning, California, United States, 92220
        • Advanced Clinical Research/Rancho Paseo Medical Group
      • Buena Park, California, United States, 90620
        • American Clinical Trials
      • Canoga Park, California, United States, 91304
        • San Fernando Valley Hlth Inst, LLC
      • 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
      • Roseville, California, United States, 95661
        • NorCal Endocrinology and Internal Medicine_Roseville
      • 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
        • East Coast Institute for Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Ctr For Clin Res
      • Miami, Florida, United States, 33136
        • University of Miami
      • 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
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • 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 Medical Research Institute_Honolulu
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Gurnee, Illinois, United States, 60031
        • Clinical Invest Special_Gurnee
      • Springfield, Illinois, United States, 62711
        • Central Illinois Diabetes and Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diab & Endo Res Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Diab & Endo Ctr
    • 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 Hlth Res Institute
      • Rockville, Maryland, United States, 20852
        • Endo And Metab Cons
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare, PLC.
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes & Endo Specialists Inc
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Phys. Clinic
      • Omaha, Nebraska, United States, 68198-3020
        • Univ of Nebraska Medical CTR
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Inc-Vegas
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Southern NH Diabetes and Endo_Nashua
    • 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, 27514
        • University of 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
      • 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
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University_Portland
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group Inc
      • Indiana, Pennsylvania, United States, 15701
        • Indiana-Armstrong Endocrinology Associates
    • 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, 24541-2834
        • Danville Internal Medicine Inc
      • Newport News, Virginia, United States, 23606
        • TPMG Clinical Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc

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

18 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 type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.
  • HbA1c 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) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
  • Body mass index (BMI) equal to or below 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 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin icodec
Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
Drug: Insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
Active Comparator: Insulin glargine
Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
Drug: Insulin glargine
Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

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 52
Change in HbA1c from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
Baseline (week 0), Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
Time Frame: From week 48 to week 52
Percentage of time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 48 to week 52 is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
From week 48 to week 52
Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline (week 0), Week 52
Change in FPG from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
Baseline (week 0), Week 52
Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52
Time Frame: From baseline (week 0) to week 52
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
From baseline (week 0) to week 52
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52
Time Frame: From baseline (week 0) to week 52
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia 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 main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
From baseline (week 0) to week 52
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) Until Week 52
Time Frame: From baseline (week 0) to week 52
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. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on main-on-treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
From baseline (week 0) to week 52
Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83
Time Frame: From baseline (week 0) to week 83
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), 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 subject was considered exposed to trial product.
From baseline (week 0) to week 83
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83
Time Frame: From baseline (week 0) to week 83
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) is presented. Clinically significant hypoglycaemia 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 on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: The end of trial visit (V63), 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 subject was considered exposed to trial product.
From baseline (week 0) to week 83
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) Until Week 83
Time Frame: From baseline (week 0) to week 83
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. Clinically significant hypoglycaemia is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemic episode is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on on-treatment period. On-treatment period started at the date of first dose of trial product as recorded on the eCRF and ended at the first date of any of the following: The end of trial visit (V63), 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. On-treatment period was the period in which a participant was exposed to trial product.
From baseline (week 0) to week 83
Mean Weekly Insulin Dose
Time Frame: From week 50 to week 52
Mean weekly insulin dose from week 50 to week 52 is presented. The outcome data was evaluated based on main on treatment period. Main-on-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the end-date of the on-treatment period or week 52. On-treatment period started with onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.
From week 50 to week 52
Change in Body Weight
Time Frame: Baseline (week 0), Week 52
Change in body weight from baseline (week 0) to week 52 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
Baseline (week 0), Week 52
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
Time Frame: From week 48 to week 52
Percentage of time spent < 3.0 mmol/L (54 mg/dL) from week 48 to week 52 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
From week 48 to week 52
Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
Time Frame: From week 48 to week 52
Percentage of time spent > 10 mmol/L (180 mg/dL) is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomization 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), death for participants who died before any of the above.
From week 48 to week 52

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 (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)

November 25, 2020

Primary Completion (Actual)

May 29, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-4477
  • U1111-1247-3878 (Other Identifier: World Health Organization (WHO))
  • 2020-000442-34 (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

product manufactured in and exported from the U.S.

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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