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)
NCT ID: NCT04795531
Last Updated: 2024-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
588 participants
INTERVENTIONAL
2021-03-24
2022-06-23
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Once weekly insulin icodec + once daily placebo
Participants will get once daily and once weekly injections
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
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
Once weekly placebo and once daily insulin degludec
Participants will get once daily and once weekly injections
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
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
Interventions
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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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Lakeview Clinical Research, LLC
Guntersville, Alabama, United States
American Clinical Trials
Buena Park, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
First Valley Medical Group
Lancaster, California, United States
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, United States
Arcturus Healthcare, PLC
Troy, Michigan, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Providence Health Partners Ctr
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
Texas Diab & Endo, P.A.
Round Rock, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
STAT Research
Buenos Aires, , Argentina
Centro de Investigación Clínica
CABA, , Argentina
Medical Center of Diabetes and Nutrition
CABA, , Argentina
Instituto de Clínica Médica y Diabetes
Mendoza, , Argentina
Universitätsklinik für Innere Medizin Graz
Graz, , Austria
Universitätsklinik für Innere Medizin
Graz, , Austria
Barmh. Brüder Linz, Konventspital
Linz, , Austria
Gesundheitszentrum Hetzendorf
Vienna, , Austria
Hanusch-Krankenhaus, Wien
Vienna, , Austria
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
Curitiba, Paraná, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, Canada
Eastern Health Authority
St. John's, Newfoundland and Labrador, Canada
LMC Diabetes & Endocrinology (Barrie)
Barrie, Ontario, Canada
LMC ClinRsrh Inc.Brampton
Brampton, Ontario, Canada
LMC (Thornhill)
Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
Etobicoke, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, Canada
Bluewater Clin Res Group,Inc
Sarnia, Ontario, Canada
Centricity Research LMC
Toronto, Ontario, Canada
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, Canada
ViaCar Recherche Clinique Inc
Brossard, Quebec, Canada
Clinique de Recherche Medpharmgene Inc.
Montreal, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University_Zhenjiang
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Ji'nan, Shandong, China
Shanghai Tenth People's Hsopital, Tongji University
Shanghai, Shanghai Municipality, China
Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Edumed Broumov
Broumov, , Czechia
Diahelp - diabetologie
Pardubice, , Czechia
DIALINE s.r.o.
Plzeň 3, , Czechia
Diabet2 s.r.o.
Prague, , Czechia
EUC Klinika Praha a.s.
Prague, , Czechia
Fledip s.r.o.
Prague, , Czechia
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, , Denmark
Sydvestjysk Sygehus Esbjerg
Esbjerg, , Denmark
Steno Diabetes Center Cph_Steno Diabetes Center Cph
Hellerup, , Denmark
Hvidovre Hospital Endokrinologisk forsk. afs. 159
Hvidovre, , Denmark
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, , France
Centre Hospitalier de Narbonne
Narbonne, , France
Ap-Hp-Hopital Bichat-Claude Bernard-1
Paris, , France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
Pessac, , France
Hospices Civils de Lyon-Hopital Lyon Sud-1
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-3
Saint-Herblain, , France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
Toulouse, , France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, , France
Arechavaleta Granell María del Rosario
Guadalajara, Jalisco, Mexico
Investigación Médica Sonora S.C.
Hermosillo, Sonora, Mexico
Advanced Clinical Research LLC
Bayamón, , Puerto Rico
Changhua Christian Hospital
Changhua, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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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.
Philis-Tsimikas A, Krogsdahl Bache J, Fu A, Kellerer M, Salvesen-Sykes K, Bain SC. Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec. Diabetes Ther. 2025 Aug;16(8):1615-1631. doi: 10.1007/s13300-025-01745-4. Epub 2025 Jun 4.
Riddell MC, Heller S, Carstensen L, Rocha TMP, Kehlet Watt S, Woo VC. The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5. Diabetologia. 2025 Jul;68(7):1416-1422. doi: 10.1007/s00125-025-06414-6. Epub 2025 Apr 5.
Li Y, Kar S, Li C, Liu M, Luan Z, Yuan G, Zhong X, Mu Y. Once-Weekly Insulin Icodec Versus Once-Daily Insulin Degludec in Insulin-Naive Chinese Participants with Type 2 Diabetes: A Post Hoc Analysis of ONWARDS 3. Diabetes Ther. 2025 Apr;16(4):685-699. doi: 10.1007/s13300-025-01701-2. Epub 2025 Feb 28.
Lingvay I, Asong M, Desouza C, Gourdy P, Kar S, Vianna A, Vilsboll T, Vinther S, Mu Y. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023 Jul 18;330(3):228-237. doi: 10.1001/jama.2023.11313.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1247-5218
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000472-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1436-4479
Identifier Type: -
Identifier Source: org_study_id