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
3 other identifiers
interventional
1,085
10 countries
311
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Mar 2021
311 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2022
CompletedResults Posted
Study results publicly available
August 26, 2025
CompletedJune 16, 2026
May 1, 2026
1.4 years
February 17, 2021
August 7, 2025
May 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to week 52 is presented.
Baseline (week 0), week 52
Secondary Outcomes (6)
Time From Baseline to Treatment Discontinuation or Intensification
From baseline (week 0) to week 52
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction
Baseline (week 0), week 52
Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain
At end of treatment (week 52)
Number of Severe Hypoglycaemic Episodes (Level 3)
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)
From baseline (week 0) to week 57
- +1 more secondary outcomes
Study Arms (2)
Insulin icodec with DoseGuide
EXPERIMENTALParticipants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
Once daily basal insulin analogues
ACTIVE COMPARATORParticipants randomised to basal insulin analogue injections once daily
Interventions
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (311)
Univ of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Lakeview Clinical Research, LLC
Guntersville, Alabama, 35976, United States
Pri Med Grp dba/Gil Ctr Fam
Gilbert, Arizona, 85296, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72204, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Advanced Clinical Research/Rancho Paseo Medical Group
Banning, California, 92220, United States
American Clinical Trials
Buena Park, California, 90620, United States
San Fernando Valley Hlth Inst, LLC
Canoga Park, California, 91304, United States
Med Center Medical Clinic
Carmichael, California, 95608, United States
Headlands Research California, LLC
Escondido, California, 92025, United States
Valley Research
Fresno, California, 93720, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250, United States
Diabetes/Lipid Mgmt & Res Ctr
Huntington Beach, California, 92648, United States
Altman Clin & Trans Res Inst
La Jolla, California, 92037, United States
Scripps Whittier Diabetes Inst
La Jolla, California, 92037, United States
First Valley Medical Group
Lancaster, California, 93534, United States
Clinical Trials Research_Sacramento
Lincoln, California, 95821, United States
Torrance Clin Res Inst, Inc.
Lomita, California, 90717, United States
Adventist Health White Memorial
Los Angeles, California, 90033, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262, United States
San Diego Family Care
San Diego, California, 92111, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, 94583, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978, United States
Handelsman Yehuda
Tarzana, California, 91356-3551, United States
Diabetes Research Center
Tustin, California, 92780, United States
Coastal Metabolic Research Center
Ventura, California, 93003, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
MedStar Diabetes Institute
Washington D.C., District of Columbia, 20010, United States
Clinical Res Of W Florida Inc
Clearwater, Florida, 33765, United States
Revival Research
Doral, Florida, 33122, United States
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, 32216, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216, United States
University Of Miami
Miami, Florida, 33136, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757, United States
Suncoast Clin Res Port Richey
New Port Richey, Florida, 34652, United States
Florida Institute for Clinical research
Orlando, Florida, 32825, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684-3609, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, 33401, United States
Clinical Research of Cent FL
Winter Haven, Florida, 33880, United States
Emory University SOM
Atlanta, Georgia, 30303, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, 30046, United States
Endo Res Solutions Inc
Roswell, Georgia, 30076, United States
Endo Res Solutions, Inc
Roswell, Georgia, 30076, United States
RNA America Health Sciences
Sugar Hill, Georgia, 30518, United States
East West Med Res Inst
Honolulu, Hawaii, 96814, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Central Illinois Diabetes and Clinical Research
Springfield, Illinois, 62711, United States
American Health Network of Indiana, LLC_Avon_0
Avon, Indiana, 46123, United States
Clinical Research Advantage, Inc.-Evansville
Evansville, Indiana, 47714, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas, 66606, United States
St Elizabeth Physicians Heart
Covington, Kentucky, 41011, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, 42001, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MedStar Community Clin Res Ctr
Hyattsville, Maryland, 20782, United States
Endo and Metab Consultants
Rockville, Maryland, 20852, United States
MassResearch, LLC_Waltham
Waltham, Massachusetts, 02453, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620, United States
Arcturus Healthcare, PLC.
Troy, Michigan, 48098, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, 63017, United States
Jefferson City Medical Group, PC
Jefferson City, Missouri, 65109, United States
St Johns Health System
Springfield, Missouri, 65807-7304, United States
Rocky Mountain Health Network
Billings, Montana, 59102, United States
Methodist Physicians Clin
Omaha, Nebraska, 68114, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, 68198-3020, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89148, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03060, United States
Southern New Hampshire Diabete
Nashua, New Hampshire, 03060, United States
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico, 87102, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
N.Y. Total Medical Care PC
Brooklyn, New York, 11215, United States
Northwell Health Div of Endo
Great Neck, New York, 11021, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553, United States
CTSI Research Center
New York, New York, 10016, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, 11787, United States
Staten Island Diabetes
Staten Island, New York, 10301-3914, United States
SUNY Upstate Medical University_Syracuse_0
Syracuse, New York, 13131, United States
Southgate Medical Group, LLP
West Seneca, New York, 14224, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
Physicians East Endocrinology
Greenville, North Carolina, 27834, United States
Medication Management, LLC
Raleigh, North Carolina, 27609, United States
Accellacare
Wilmington, North Carolina, 28401, United States
Ardmore Family Practice_Winston Salem
Winston-Salem, North Carolina, 27103, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718, United States
The Ohio State University Medical Center
Columbus, Ohio, 43203, United States
Providence Health Partners Ctr
Dayton, Ohio, 45439, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, 44060, United States
Clinical Research Source Inc
Perrysburg, Ohio, 43551, United States
New Venture Medical Research
Wadsworth, Ohio, 44281, United States
Intend Research
Norman, Oklahoma, 73069, United States
Oregon Health & Science University_Portland_0
Portland, Oregon, 97239, United States
Heritage Valley Multispeciality Group Inc
Beaver, Pennsylvania, 15009, United States
Indiana-Armstrong Endocrinology Associates
Indiana, Pennsylvania, 15701, United States
Tristar Clin Investigations, PC
Philadelphia, Pennsylvania, 19114, United States
The Diabetes Center, LLC
Murrells Inlet, South Carolina, 29576, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Athens Medical Group
Athens, Tennessee, 37303, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, 38133, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, 37411, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
HealthStar Physicians PC
Morristown, Tennessee, 37813, United States
Amarillo Med Spec LLP
Amarillo, Texas, 79106, United States
Texas Diab & Endo, P.A.
Austin, Texas, 78731, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302, United States
PrimeCare Medical Group
Houston, Texas, 77024, United States
Juno Research, LLC
Houston, Texas, 77074, United States
Endocrine And Psychiatry Center
Houston, Texas, 77095, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
Medical Colleagues-Texas LLP
Katy, Texas, 77450, United States
Fmc Science, Llc
Lampasas, Texas, 76550, United States
Andres Garcia-Zuniga, MD, P.A
Laredo, Texas, 78041, United States
Texas Diab & Endo, P.A.
Round Rock, Texas, 78681, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
NE Clin Res of San Antonio
San Antonio, Texas, 78233, United States
Simcare Medical Research, LLC
Sugar Land, Texas, 77478, United States
Elite Medical Care
Sugar Land, Texas, 77479, United States
Javara Inc.
The Woodlands, Texas, 77382, United States
Wade Family Medicine
Bountiful, Utah, 84010, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
Chatham Family Medical Center
Chatham, Virginia, 24531, United States
Danville Internal Medicine Inc
Danville, Virginia, 24541-2834, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
Clinical Investigation Specialists Inc, Kenosha
Kenosha, Wisconsin, 53144, United States
UMHAT - Burgas AD
Burgas, 8000, Bulgaria
Medical Center Cherven bryag EOOD
Cherven Bryag, 5980, Bulgaria
Medical Center Zdrave Lom EOOD
Lom, 3600, Bulgaria
MHAT - Pazardzhik AD
Pazardzhik, 4401, Bulgaria
UMHAT Kanev AD
Rousse, 7000, Bulgaria
MHAT Dr. Bratan Shukerov
Smolyan, 4700, Bulgaria
Medical Institute of Ministry of interior
Sofia, 1606, Bulgaria
UMHAT Sofiamed EAD
Sofia, 1797, Bulgaria
UMHAT Sveta Marina EAD, Clinic of Internal Diseases
Varna, 9010, Bulgaria
Medical center - Varna
Varna, Bulgaria
MHAT Sveti Panteleimon - Yambol AD
Yambol, 8600, Bulgaria
LMC Clin Res Inc. Calgary
Calgary, Alberta, T2H 2G4, Canada
The Bailey Clinic
Red Deer, Alberta, T4N 6V7, Canada
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6, Canada
BC Diabetes Canada
Vancouver, British Columbia, V5Y 3W2, Canada
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Dr. M.B. Jones Inc
Victoria, British Columbia, V8V 4A1, Canada
Rivergrove Medical Clinic
Winnipeg, Manitoba, R2V 4W3, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Eastern Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, L4N 7L3, Canada
Centricity Research LMC (Toronto)
Brampton, Ontario, L6S 0C6, Canada
Dawson Clinical Research
Cambridge, Ontario, N1H 1B1, Canada
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, N1R 7L6, Canada
Saul Vizel Pro. Med. Corp
Cambridge, Ontario, N1R 7R1, Canada
LMC Clinical Res Thornhill
Concord, Ontario, L4K 4M2, Canada
Medical Trust Clinics, Inc.
Courtice, Ontario, L1E2J5, Canada
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, M9R 4E1, Canada
Janik Research
Greater Sudbury, Ontario, P3B 4H5, Canada
Four Corners Walk-In Clinic
Greater Sudbury, Ontario, P3E 1Y8, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, L8L 5G8, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8M 1K7, Canada
Milestone Research
London, Ontario, N5W 6A2, Canada
St. Joseph's Hospital
London, Ontario, N6A 4V2, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, N6G 2M1, Canada
My Endo Diabetes & Endo Cent
Markham, Ontario, L3P 7P2, Canada
Malton Medical Clinic
Mississauga, Ontario, L4V1P1, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, K2J 0V2, Canada
Manna Research Ottawa
Nepean, Ontario, K2J 4A7, Canada
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
LMC Oakville
Oakville, Ontario, L6M 1M1, Canada
Enhanced Care Clinic
Oshawa, Ontario, L1J 1T4, Canada
Dr. James Cha
Oshawa, Ontario, L1J 2K1, Canada
The Ottawa Hospital Riverside Campus
Ottawa, Ontario, K1H7W9, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2, Canada
Bluewater Clin Res Group,Inc
Sarnia, Ontario, N7T 4X3, Canada
Canadian Centre for Research on Diabetes
Smiths Falls, Ontario, K7A 4W8, Canada
Winterberry Family Medicine
Stoney Creek, Ontario, L8J 0B6, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2, Canada
Keele Medical
Toronto, Ontario, M3M3E5, Canada
Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, M4C 5T2, Canada
LMC Endo Centres Ltd.(Bayview)
Toronto, Ontario, M4G 3E8, Canada
Leadership Sinai Centre for Diabetes, Mount Sinai Hospital
Toronto, Ontario, M5T 3L9, Canada
Dr Anil K Gupta Med Prof Corp
Toronto, Ontario, M9V 4B4, Canada
Clinique Santé Dix30
Brossard, Quebec, J4Y 0E2, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, J4Z 2K9, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Ctr de recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
Manna Research Mirabel
Mirabel, Quebec, J7J 2K8, Canada
Recherche GCP Research
Montreal, Quebec, H1Y 3H5, Canada
Clinique de Recherche Medpharmgene Inc.
Montreal, Quebec, H2K 1H2, Canada
IRCM
Montreal, Quebec, H2W 1R7, Canada
LMC Clinical Research, Inc. (Montreal Glen)
Montreal, Quebec, H4A 2C6, Canada
Applied Med Inf Res
Montreal, Quebec, H4A 3T2, Canada
Centre Medical Acadie
Montreal, Quebec, H4N 2W2, Canada
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, H9R 4S5, Canada
Clin des Mal Lipid de Quebec
Québec, Quebec, G1V 4W2, Canada
Diex Recherche Joliette
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, H4T 1Z9, Canada
Ctr Méd. et pro d l'Ost d port
Saint-Marc-des-Carrieres, Quebec, G0A 4B0, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6, Canada
Recherche Clinique Sigma inc
Québec, G1G 5X1, Canada
Diex Recherche Quebec
Québec, G1V 4T3, Canada
Centre de Recherche Saint-Louis
Québec, G1W 4R4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Diabetespraxis Mergentheim
Bad Mergentheim, 97980, Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, 14612, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607, Germany
Dr. Milek medikum
Hohenmölsen, 06679, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, 48153, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758, Germany
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, 66780, Germany
Med.Versorgungszentrum Riesa-Dr. Bieler
Riesa, 01587, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386, Germany
MZM Praxis Drs. Erlinger
Stuttgart, 70378, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239, Germany
NIMTS Army Share Fund Hospital
Athens, 115 21, Greece
Iatriko Psychicou Private Clinic
Athens, 115 25, Greece
'G. Gennimatas' General Hospital of Athens
Athens, 115 27, Greece
Group Euroclinic - Athens Euroclinic
Athens, 11521, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, 17562, Greece
General Hospital Of Athens Korgialenio Benakio H.R.C. - Department of Endocrinology
Athens, GR-11526, Greece
Gen Hosp Athens Ippokrateio,B' Uni Clinic Internal Medicine
Athens, GR-11527, Greece
Univ Gen Hospital Larisa
Larissa, 41110, Greece
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, 54635, Greece
AHEPA General University Hospital
Thessaloniki, 54636, Greece
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, 54642, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645, Greece
"Thermi" Private Hosital
Thessaloniki, 57001, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, 57010, Greece
"Ippokrateio" General Hosp Thessaloniki, A' Internal Med
Thessaloniki, GR-54642, Greece
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, 2900, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, 1036, Hungary
Szent Margit Kórház
Budapest, 1032, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
Budapest, 1042, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1089, Hungary
MED-TIMA Kft.
Budapest, 1132, Hungary
MH Egészségügyi Központ
Budapest, 1134, Hungary
Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft.
Budapest, 1152, Hungary
Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, 9700, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, 8900, Hungary
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, 20-538, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, 81-338, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Szpital Specjalistyczny Nr 2 Poradnia Diabetologiczna
Bytom, 41-902, Poland
NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
Gdansk, 80-858, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, 31-261, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132, Poland
Gabinet Lekarski Katarzyna Cypryk
Lodz, 90-553, Poland
Pro Salus Centrum Medyczne
Lodz, 91-473, Poland
Qualimed
Lodz, 91-849, Poland
Katedra i Klinika Chorob Wewnetrznych AM w Lublinie
Lublin, 20-081, Poland
Oddzial Chorób - Wewn.
Poznan, 60-834, Poland
Velocity Nova Sp. z o.o.
Puławy, 24-100, Poland
Niepubliczny Zakład Opieki Zdrowotnej Beta-Med
Rzeszów, 35-073, Poland
Lubelskie Centrum Diagnostyczne Tomasz Blicharski
Świdnik, 21-040, Poland
NBR Polska Tomasz Klodawski
Warsaw, 00-710, Poland
SP CSK Klinika Diabetologii i Chorob Wewnetrznych
Warsaw, 02-097, Poland
Master Center for Poland
Warsaw, PL-02-274, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Poradnia dla Chorych na Cukrzycę
Zabrze, 41-800, Poland
Velocity Nova Sp. z o.o.
Staszów, Świętokrzyskie Voivodeship, 28-200, Poland
Instituto De Endronilogia Diabetes Y Metabolismo
Bayamón, 00961, Puerto Rico
Manati Ctr For Clin Research
Manati, 00674, Puerto Rico
Consultorio Medico
San Juan, 00921, Puerto Rico
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000, Serbia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, 11000, Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, 34000, Serbia
Policlinic for diabetes
Zaječar, 19000, Serbia
Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
Adana, 01250, Turkey (Türkiye)
Ankara Üniversitesi Tıp Fakültesi İbni Sina Hastanesi-Endokrinoloji
Ankara, 06100, Turkey (Türkiye)
Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi
Eskişehir, 26040, Turkey (Türkiye)
Gaziantep Üniversitesi Hastanesi
Gaziantep, 27070, Turkey (Türkiye)
Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
Hatay, 31060, Turkey (Türkiye)
Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
Istanbul, 34303, Turkey (Türkiye)
Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji
Istanbul, 34371, Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji
Istanbul, 34390, Turkey (Türkiye)
Haydarpaşa Numune Eğitim ve Araştırma Hastanesi
Istanbul, 34718, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722, Turkey (Türkiye)
Umraniye Egitim ve Arastirma Hastanesi
Istanbul, 34760, Turkey (Türkiye)
T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-Endokrinoloji
Izmir, 35340, Turkey (Türkiye)
Erciyes Üniversitesi Hastanesi- Endokrinoloji
Kayseri, 38039, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi
Yüreğir/Adana, 1370, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 36106652RESULTPhilis-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.
PMID: 40465144DERIVEDRiddell 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.
PMID: 40186685DERIVEDBillings 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.
PMID: 39699848DERIVEDPolonsky 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.
PMID: 39368488DERIVEDBajaj 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.
PMID: 37748181DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Office (2834)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2021
First Posted
February 18, 2021
Study Start
March 1, 2021
Primary Completion
August 12, 2022
Study Completion
August 29, 2022
Last Updated
June 16, 2026
Results First Posted
August 26, 2025
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com