Diabetes Mellitus, Type 1Phase 3ONWARDS 11NCT07076199
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
A Phase 3 study testing Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 182 sites in 8 countries.
Trial summary
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin icodec, Insulin glargine and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 877 participants
- Where
- 182 sitesin 8 countries
- Study dates
- 11 Aug 2025to 1 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
- Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Trial locations and contacts
182 sites in 8 countries.
182 sites in 8 countries
United States103 sites
AMC Community Endocrinology
Albany, New York, 12203
Albuquerque Clinical Trials Inc.
Albuquerque, New Mexico, 87102
Amarillo Medical Specialists
Amarillo, Texas, 79124
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diab Endo ATX N Mopac EXPR
Austin, Texas, 78731
Texas Diabetes & Endocrinology
Austin, Texas, 78749
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804
Holston Medical Group_Bristol
Bristol, Tennessee, 37620
Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
Northwestern University
Chicago, Illinois, 60611
University Of Chicago
Chicago, Illinois, 60637-1447
Profound Research LLC
Clarkston, Michigan, 48346
Cleveland Clinic_Cleveland
Cleveland, Ohio, 44195
Centricity Research Columbus
Columbus, Georgia, 31904
The Ohio State University Medical Center
Columbus, Ohio, 43203
John Muir Health
Concord, California, 94520
Cullman Clinical Trials
Cullman, Alabama, 35055
Alliance Clinical Network
Dallas, Texas, 75203
Thyroid Endocrinology & Diabetes PA
Dallas, Texas, 75208
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
North Texas Endocrine Center
Dallas, Texas, 75231
Research Institute Of Dallas
Dallas, Texas, 75231
Precision Endo - Revival
Denton, Texas, 76210
Epic Medical Research
DeSoto, Texas, 75115
Frontier Medical Ctr
El Paso, Texas, 79935
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113
Headlands Research California, LLC
Escondido, California, 92025
Profound Research LLC
Farmington Hills, Michigan, 48334
Northeast Research Institute
Fleming Island, Florida, 32003
Elite Clinical Research Center
Flint, Michigan, 48532
N. Texas Diab & Endo - Prime
Flower Mound, Texas, 75028
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132
Clinical Res of Central Ca
Fresno, California, 93704
Providence Medical Foundation
Fullerton, California, 92835
Optumcare Clinical Trials,LLC-Golden
Golden, Colorado, 80401
Prevea Health
Green Bay, Wisconsin, 54303
Physicians East Endocrinology
Greenville, North Carolina, 27834
Prisma Health Endo Spc Thy Ctr
Greenville, South Carolina, 29605
Encore Medical Research LLC
Hollywood, Florida, 33024
Houston Endocrinology Center
Houston, Texas, 77040
The Endocrine Center
Houston, Texas, 77079
Amir Ali Hassan, MD, PA
Houston, Texas, 77089
Rocky Mt Clin Res, LLC
Idaho Falls, Idaho, 83404-7596
Indiana Uni School of Med-Ped
Indianapolis, Indiana, 46202-5209
Northeast Research Institute
Jacksonville, Florida, 32204
Scripps Whittier Diabetes Inst
La Jolla, California, 92037
Palm Research Center Inc.
Las Vegas, Nevada, 89148
Physicians Research Assoc. LLC
Lawrenceville, Georgia, 30046
Loma Linda University Faculty Medical Clinics
Loma Linda, California, 92354
Pacific Clinical Studies
Los Alamitos, California, 90720
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
RGV Endocrine Center
McAllen, Texas, 78503
Tekton Research
McKinney, Texas, 75069
Life Spring Research Foundation LLC
Miami, Florida, 33130
International Diabetes Center
Minneapolis, Minnesota, 55416
Centricity Rsrch MHCity Multi
Morehead City, North Carolina, 28557
MidState Endocrine Associates
Nashville, Tennessee, 37203
Vanderbilt Medical Center_Nashville
Nashville, Tennessee, 37212
Centricity Res New Bern Multispeciality
New Bern, North Carolina, 28562
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
NYC Research, Inc.
New York, New York, 10016
NYU Langone Orthopedic Center
New York, New York, 10017
Alliance for Multispecialty Research
Norman, Oklahoma, 73069
Lynn Institute of Norman
Norman, Oklahoma, 73069
West Orange Endocrinology
Ocoee, Florida, 34761
Rio Clinical Trials
Ogden, Utah, 84404
Lynn Institute - East OKC
Oklahoma City, Oklahoma, 73111
MedStar Health Research Institute
Olney, Maryland, 20832
QCR Network
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, 34684
Pasadena Clinical Trials
Pasadena, California, 91101
Center for Diab,Obes & Metab
Pembroke Pines, Florida, 33024
SRA Trials-Broward
Pembroke Pines, Florida, 33024
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
WestenU Health
Pomona, California, 91766
Hanson Clinical Research Center
Port Charlotte, Florida, 33952
Accellacare of Raleigh
Raleigh, North Carolina, 27609
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076
Be Well Clinical Studies
Round Rock, Texas, 78681
Texas Diabetes & Endocrinology_Round Rock
Round Rock, Texas, 78681
Northeast Clinical Research of San Antonio
San Antonio, Texas, 78233
Alliance Clinical Network
San Diego, California, 92120
Mills Health Center
San Mateo, California, 94401
Center for Endocrine DM and Metabolic Disorders
Santa Clarita, California, 91321
Endeavor Health
Skokie, Illinois, 60077
UVM Endocrinology
South Burlington, Vermont, 05403
Saint Louis University
St Louis, Missouri, 63103
Washington University
St Louis, Missouri, 63110
Latin Clinical Trial Ctr
Tamarac, Florida, 33321
Bayside Clinical Research
Tampa, Florida, 33607
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
University Clin Investigators
Tustin, California, 92780
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, 78596
Iowa Diabetes Research
West Des Moines, Iowa, 50266
Metabolic Research Institute Inc
West Palm Beach, Florida, 33401
University at Buffalo
Williamsville, New York, 14221
Accellacare Wilmington
Wilmington, North Carolina, 28401
Canada17 sites
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6
Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4
University of Calgary
Calgary, Alberta, T2T 5C7
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8L 5G4
Ctr de recherche Clinique de Laval
Laval, Quebec, H7T 2P5
Western University Centre for Studies in Fam Med
London, Ontario, N6G 2M1
Centricity Research Mirabel
Mirabel, Quebec, J7J 2K8
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Clinique Endocrinologie OASIS.
Montreal, Quebec, H4J 1E3
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, G1V 4W2
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, J6X 4P7
Centricity Research Toronto LMC Multispec
Toronto, Ontario, M4G 3E8
Centricity Research LMC (Toronto)
Toronto, Ontario, M9W 4L6
Vancouver General Hospital_Vancouver_0
Vancouver, British Columbia, V5Z 1M9
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Poland17 sites
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, 80-214
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132
Zanamed Medical Clinic Sp. z o.o.
Lublin, 20-601
Reumed Sp. z o.o.
Lublin, 20-607
ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spolka cywilna
Opole, 45-301
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600
Formed 2 Sp. z o.o.
Oświęcim, 32-600
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Piotrkow Trybunalski, 97-300
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
Poznan, 60-354
Maciej Wiza Gaja Poradnie Lekarskie
Poznan, 61-251
Metabolica Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
Zespol Wojewodzkich Przychodni Specjalistycznych W Katowicach SPZOZ
Zabrze, 41-800
Etg Zamosc Sp. z o.o.
Zamość, 22-400
Germany16 sites
Diabetespraxis Mergentheim
Bad Mergentheim, 97980
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597
DSP Bochum, Diabetes- und Stoffwechselpraxis
Bochum, 44869
Uniklinik TU Dresden - Med. Klinik III
Dresden, 01307
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
Eisenach, 99817
InnoDiab Forschung GmbH
Essen, 45136
MVZ Diabeteszentrum Dr. Tews GmbH
Gelnhausen, 63571
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, 21109
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607
Die Praxis am Ludwigsplatz
Ludwigshafen, 67059
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, 48153
Institut für Diabetesforschung Osnabrück
Osnabrück, 49080
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239
Romania14 sites
CMI Dr. Pletea Noemi SRL
Bacau, 600154
Minimed S.R.L.
Bacau, 600238
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, 500283
SC Nutrilife SRL
Bucharest, 013764
Diabs&Nutricare Srl
Bucharest, 040172
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Constanța, 900591
S.C. Top Diabet Srl
Craiova, Dolj, 200515
SC Diamed Obesity SRL
Galati, 800291
Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, 100179
S.C. Dianutrilife Medica S.R.L.
Ploieşti, 100561
Clinica Korall S.R.L. Satu Mare
Satu Mare, 440055
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava, 720224
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300723
Australia7 sites
St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department
Fitzroy, Victoria, 3065
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081
Macquarie University - Clinical Trials Unit
Macquarie Park, New South Wales, 2109
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046
The Royal Melbourne Hospital - Diabetes & Endocrinology Department
Parkville, Victoria, 3050
Townsville University Hospital
Townsville, Queensland, 4814
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, 2500
Slovakia6 sites
DIABEDA s.r.o.
Bratislava, 831 06
MEDISPEKTRUM s.r.o.
Bratislava, 851 01
Diab - Int, s.r.o.
Bytča, 014 01
DIOLI s.r.o.
Košice, 040 01
HUMAN-CARE, s.r.o.
Košice, 040 01
DIADAN, s.r.o. Kosice
Košice, 04011
Puerto Rico2 sites
Centro de Endo Altagracia
Bayamón, 00959
Advanced Clinical Research LLC
Bayamón, 00961
About this study
Official title: A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin icodec, Insulin glargine, Insulin aspart
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin icodecDrug
Insulin icodec will be administered as subcutaneous injection
Insulin glargineDrug
Insulin glargine will be administered as subcutaneous injection.
Insulin aspartDrug
Insulin aspart will be administered as a subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Insulin icodec + insulin aspart | Experimental | Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart . Receives: Drug: Insulin icodec; Drug: Insulin aspart |
| Insulin glargine+ insulin aspart | Active comparator | Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart. Receives: Drug: Insulin glargine; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated haemoglobin (HbA1c)
Measured in percentage (%)-points.
Measured: From baseline (week 0) to week 26
Secondary outcomes (9)
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Measured in %-points.
Measured: From baseline (week-2-0) to week 22-26
Time spent less than (<)3.0 mmol/L (54 mg/dL)
Measured in % of time.
Measured: From week 22 to week 26
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)
Measured in %-points.
Measured: From baseline (week-2-0) to week 22-26
Number of severe hypoglycaemic episodes (level 3)
Measured as number of episodes.
Measured: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter)
Measured as number of episodes.
Measured: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)
Measured as number of episodes.
Measured: From baseline (week 0) to week 31
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])
Measured as number of episodes.
Measured: From baseline (week 0) to week 31
Mean total weekly insulin dose
Measured in insulin units.
Measured: From week 24 to week 26
Change in body weight
Measured in Kilogram (kg).
Measured: From baseline (week 0) to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start11 Aug 2025
- Primary completion25 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 877 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076199
- Sponsor's protocol ID
- NN1436-8182
- Other IDs
- U1111-1310-7017, 2024-519945-31
- Acronym
- ONWARDS 11
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07076199
- Acronym / sponsor ID
- ONWARDS 11 / NN1436-8182
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 877 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin icodec + insulin aspart | Experimental | Drug: Insulin icodec, Drug: Insulin aspartParticipants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart . |
| Insulin glargine+ insulin aspart | Active comparator | Drug: Insulin glargine, Drug: Insulin aspartParticipants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
- HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
- Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.
Key exclusion criteria (8 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous participation in this study. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
- Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin icodecInsulin icodec will be administered as subcutaneous injection | Drug | Insulin icodec + insulin aspart |
| Insulin glargineInsulin glargine will be administered as subcutaneous injection. | Drug | Insulin glargine+ insulin aspart |
| Insulin aspartInsulin aspart will be administered as a subcutaneous injection. | Drug | Insulin glargine+ insulin aspart, Insulin icodec + insulin aspart |
Primary outcome
Change in glycosylated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to week 26
Measured in percentage (%)-points.
9 secondary outcomes
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Time frame: From baseline (week-2-0) to week 22-26
Time spent less than (<)3.0 mmol/L (54 mg/dL)
Time frame: From week 22 to week 26
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL)
Time frame: From baseline (week-2-0) to week 22-26
Number of severe hypoglycaemic episodes (level 3)
Time frame: From baseline (week 0) to week 31
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 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) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3)
Time frame: From baseline (week 0) to week 31
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL])
Time frame: From baseline (week 0) to week 31
Mean total weekly insulin dose
Time frame: From week 24 to week 26
Change in body weight
Time frame: From baseline (week 0) to week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
182 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin icodec, Insulin glargine and Insulin aspart in people with Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 182 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 182 sites in United States, Canada, Poland, Germany, Romania and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycosylated haemoglobin (HbA1c) (time frame: From baseline (week 0) to week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.