Weekly insulin shot could replace daily injections for diabetes

NCT ID NCT04795531

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new insulin called icodec, taken just once a week, against a standard daily insulin (degludec) in 588 adults with type 2 diabetes who had never used insulin before. Participants received either weekly icodec plus a daily placebo, or daily degludec plus a weekly placebo, for 26 weeks. The main goal was to see how well each controlled blood sugar levels. The trial is complete and may lead to a simpler insulin routine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Insulin icodec (once-weekly insulin)
What this could lead to: If successful, this could offer a more convenient once-weekly insulin option for people with type 2 diabetes, reducing the number of injections needed.
What could go wrong: This is a completed phase 3 trial, but the new insulin may not control blood sugar as well as daily insulin or could have different side effects. Individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

588 people

The number who actually took part.

Started

Mar 2021

Finished

Jun 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening. * HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. * Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. * Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a.) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b.) Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c.) Any of the following oral anti-diabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists * Body mass index (BMI) below or equal to 40.0 kg/m\^2. Exclusion Criteria: * Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening. * Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. * Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

AM Diabetes And Endocrinology Center

Bartlett, Tennessee, 38133, United States
Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, 8200, Denmark
Accellacare

Wilmington, North Carolina, 28401, United States
Advanced Clinical Research LLC

Bayamón, 00959, Puerto Rico
Advanced Clinical Research/Rancho Paseo Medical Group

Banning, California, 92220, United States
Advanced Research Institute

Ogden, Utah, 84405, United States
Albuquerque Clin Trials, Inc.

Albuquerque, New Mexico, 87102, United States
American Clinical Trials

Buena Park, California, 90620, United States
Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States
Ap-Hp-Hopital Bichat-Claude Bernard

Paris, 75877, France
Arcturus HC PLC Troy Med Res

Troy, Michigan, 48098, United States
Ardmore Family Practice

Winston-Salem, North Carolina, 27103, United States
BC Diabetes Canada

Vancouver, British Columbia, V5Y 3W2, Canada
Barmh. Brüder Linz, Konventspital

Linz, 4021, Austria
Beijing Pinggu Hospital

Beijing, Beijing Municipality, 101200, China
Beijing Pinggu Hospital-Endocrinology

Beijing, Beijing Municipality, 101200, China
Bluewater Clin Res Group,Inc

Sarnia, Ontario, N7T 4X3, Canada
CEDIC Centro de Investigación Clínica

CABA, C1060ABA, Argentina
CENUDIAB Centro Médico de Nutrición v Diabetes

CABA, C1440AAD, Argentina
CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil
Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada
Cangzhou People's Hospital-Endocrinology

Cangzhou, Hebei, 061000, China
Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2

Pessac, 33600, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-3

Saint-Herblain, 44800, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

Toulouse, 31054, France
Centre Hospitalier de Narbonne

Narbonne, 11100, France
Centre Hospitalier de l'Université Laval

Québec, G1V 4G2, Canada
Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada
Centre Medical Medicina Rockefeller

Lyon, 69008, France
Centre de Recherche Clinique Portes Du Sud

Vénissieux, 69200, France
Centricity Research LMC (Toronto)

Toronto, Ontario, M4G 3E8, Canada
Centro de Diabetes Curitiba

Curitiba, Paraná, 80810-040, Brazil
Changhua Christian Hospital_Metabolic Dept.

Changhua, 500, Taiwan
Changzhou No.2 People's Hospital, Yanghu Branch

Changzhou, Jiangsu, 213003, China
Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States
Chi Mei Medical Center

Tainan, 710, Taiwan
Chinese People's Liberation Army General Hospital-Endocrinology

Beijing, Beijing Municipality, 100853, China
Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China
Chrysalis Clinical Research

St. George, Utah, 84790, United States
Chung Shan Medical University Hospital

Taichung, 402, Taiwan
Clinical Investigation Specialists Inc, Kenosha

Kenosha, Wisconsin, 53144, United States
Clinical Research Source Inc

Perrysburg, Ohio, 43551, United States
Clinical Research of Cent FL

Winter Haven, Florida, 33880, United States
Clinical Trials Research_Sacramento

Lincoln, California, 95648, United States
Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States
Clinique de Recherche Medpharmgene Inc.

Montreal, Quebec, H1Y 3L1, Canada
Coastal Metabolic Research Center

Ventura, California, 93003, United States
Commonwealth Medical Clinic

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Consultorio Arechavaleta Granell María del Rosario

Guadalajara, Jalisco, 44650, Mexico
Cotton-Oneill Diabetes and End

Topeka, Kansas, 66606-2806, United States
DIALINE s.r.o.

Plzeň 3, 301 00, Czechia
Daniel G Williams MD

Perrysburg, Ohio, 43551, United States
Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, 80113, United States
Desert Oasis Hlthcr Med Group

Palm Springs, California, 92262, United States
Diab & Endo Assoc of Stark Co

Canton, Ohio, 44718, United States
Diabet2 s.r.o.

Prague, 110 00, Czechia
Diabetes & Endo Specialists Inc

Chesterfield, Missouri, 63017, United States
Diabetes Research Center

Tustin, California, 92780, United States
Diahelp - diabetologie

Pardubice, 530 02, Czechia
Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada
Dr Anil K Gupta Med Prof Corp

Toronto, Ontario, M9V 4B4, Canada
Dr. Ehud Ur

Vancouver, British Columbia, V6H 3X8, Canada
Dr. James Cha

Oshawa, Ontario, L1J 2K1, Canada
EUC Klinika Praha a.s.

Prague, 150 00, Czechia
East West Med Res Inst

Honolulu, Hawaii, 96814, United States
Eastern Health Authority

St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Edumed Broumov

Broumov, 550 01, Czechia
Elite Clinical Trials

Blackfoot, Idaho, 83221, United States
Elite Medical Care

Sugar Land, Texas, 77479, United States
Endo and Metab Consultants

Rockville, Maryland, 20852, United States
Endocrine Associates of Long Island, PC

Smithtown, New York, 11787, United States
Est Cst Inst for Rsrch,Jksnvil

Jacksonville, Florida, 32216, United States
First Valley Medical Group

Lancaster, California, 93534, United States
Fledip s.r.o.

Prague, 160 00, Czechia
Florida Institute for Clinical research

Orlando, Florida, 32825, United States
Fmc Science, Llc

Lampasas, Texas, 76550, United States
Four Rivers Clinical Research Inc

Paducah, Kentucky, 42001, United States
General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China
Gesundheitszentrum Hetzendorf

Vienna, 1120, Austria
Hanusch-Krankenhaus, Wien

Vienna, 1140, Austria
Headlands Research California, LLC

Escondido, California, 92025, United States
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

Hengshui, Hebei, 053000, China
Heritage Valley Multispeciality Group Inc

Beaver, Pennsylvania, 15009, United States
Hillcrest Clinical Research

Simpsonville, South Carolina, 29681-1538, United States
Holston Medical Group

Kingsport, Tennessee, 37660, United States
Hospices Civils de Lyon-Hopital Lyon Sud

Pierre-Bénite, 69310, France
Hvidovre Hospital Endokrinologisk forsk. afs. 159

Hvidovre, 2650, Denmark
Instituto de Clínica Médica y Diabetes

Mendoza, 5500, Argentina
Intend Research

Norman, Oklahoma, 73069, United States
Investigación Médica Sonora S.C.

Hermosillo, Sonora, 83280, Mexico
Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States
JCCT- Juno NW Houston

Houston, Texas, 77040, United States
Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States
Janik Research

Greater Sudbury, Ontario, P3B 4H5, Canada
Jinan Central Hospital

Jinan, Shandong, 250013, China
Klinik Hietzing 3. Med. Abt.

Vienna, 1130, Austria
LMC Clin Res Inc. Calgary

Calgary, Alberta, T2H 2G4, Canada
LMC Clin Rsrch Inc. (Montreal)

Saint-Laurent, Quebec, H4T 1Z9, Canada
LMC ClinRsrh Inc.Brampton

Brampton, Ontario, L6S 0C6, Canada
LMC Clinical Res Thornhill

Concord, Ontario, L4K 4M2, Canada
LMC Diabetes & Endocrinology (Barrie)

Barrie, Ontario, L4N 7L3, Canada
LMC Endo Ctr (Etobicoke) Ltd

Etobicoke, Ontario, M9R 4E1, Canada
LMC Oakville

Oakville, Ontario, L6M 1M1, Canada
LMC Research Inc. Ottawa

Nepean, Ontario, K2J 0V2, Canada
Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976, United States
Les Hopitaux de Chartres-Hopital Louis Pasteur

Le Coudray, 28630, France
Luis Rivera Colon, M.D., FACDS

Rio Piedras, 00921, Puerto Rico
Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States
Manati Ctr For Clin Research

Manati, 00674, Puerto Rico
Manna Research Ottawa

Nepean, Ontario, K2J 4A7, Canada
Master Centre for Czech Rep

Prague, 18600, Czechia
Master centre for France

Paris La Défense, 92936, France
Med Center Medical Clinic

Carmichael, California, 95608, United States
MedStar Community Clin Res Ctr

Hyattsville, Maryland, 20782, United States
Medication Management, LLC

Raleigh, North Carolina, 27609, United States
Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States
Methodist Physicians Clin

Omaha, Nebraska, 68114, United States
N.Y. Total Medical Care PC

Brooklyn, New York, 11215, United States
NE Clin Res of San Antonio

San Antonio, Texas, 78233, United States
NYU Grossman School of Med

New York, New York, 10016, United States
Nanjing Jiangning Hospital-Endocrinology

Nanjing, Jiangsu, 211199, China
NorCal Endocrinology and Internal Medicine

San Ramon, California, 94583, United States
North Texas Endocrine Center

Dallas, Texas, 75231, United States
Northwell Health Div of Endo

Great Neck, New York, 11021, United States
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Ordination Dr. Günter Sokol

Vienna, 1120, Austria
Oregon Health & Science University_Portland_0

Portland, Oregon, 97239, United States
Palm Harbor Medical Associates

Palm Harbor, Florida, 34684-3609, United States
Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89148, United States
Physician's East Endocrinology

Greenville, North Carolina, 27834, United States
Physicians Research Assoc. LLC

Lawrenceville, Georgia, 30046, United States
Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104, United States
Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8M 1K7, Canada
Prestige Clinical Research

Franklin, Ohio, 45005, United States
PrimeCare Medical Group

Houston, Texas, 77024, United States
Providence Clinical Research

North Hollywood, California, 91606, United States
Providence Health Partners Ctr

Dayton, Ohio, 45439, United States
Q & T Research Sherbrooke Inc.

Sherbrooke, Quebec, J1J 2G2, Canada
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV

Curitiba, Paraná, 80045-110, Brazil
RNA America Health Sciences

Sugar Hill, Georgia, 30518, United States
Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States
Recherche Clinique Sigma inc

Québec, G1G 5X1, Canada
Revival Research

Doral, Florida, 33122, United States
STAT Research

Buenos Aires, C1023AAB, Argentina
Saul Vizel Pro. Med. Corp

Cambridge, Ontario, N1R 7R1, Canada
Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States
Shanghai Fifth People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 200240, China
Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology

Shanghai, Shanghai Municipality, 200072, China
Simcare Medical Research, LLC

Sugar Land, Texas, 77478, United States
Southern New Hampshire Diabete

Nashua, New Hampshire, 03060, United States
Southgate Medical Group, LLP

West Seneca, New York, 14224, United States
Spectrum Medical, Inc

Danville, Virginia, 24541, United States
St Elizabeth Physicians Heart

Covington, Kentucky, 41011, United States
St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada
Steno Diabetes Center Cph_Steno Diabetes Center Cph

Hellerup, 2900, Denmark
Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States
Suncoast Clinical Research, Inc.

Palm Harbor, Florida, 34684, United States
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

Esbjerg, 6700, Denmark
TPMG Clinical Research

Newport News, Virginia, 23606, United States
Taichung Veterans General Hospital

Taichung, 407, Taiwan
Taipei Veterans General Hospital

Taipei, 112, Taiwan
Texas Diab & Endo, P.A.

Austin, Texas, 78731, United States
Texas Diab & Endo, P.A.

Round Rock, Texas, 78681, United States
The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China
The Bailey Clinic

Red Deer, Alberta, T4N 6V7, Canada
The Diabetes Center, LLC

Murrells Inlet, South Carolina, 29576, United States
The First Affiliated Hospital of Anhui Medical University-Endocrinology

Hefei, Anhui, 230061, China
The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China
The Second Hospital of Jilin University

Changchun, Jilin, 130041, China
Tianjin Medical University General Hospital-Endocrinology

Tianjin, Tianjin Municipality, 300052, China
Torrance Clin Res Inst, Inc.

Lomita, California, 90717, United States
UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States
Univ of Alabama Birmingham

Birmingham, Alabama, 35222, United States
Univ of Nebraska Medical CTR

Omaha, Nebraska, 68198-3020, United States
University Of Miami

Miami, Florida, 33136, United States
University of North Carolina

Chapel Hill, North Carolina, 27517, United States
Universitätsklinik für Innere Medizin

Graz, 8036, Austria
Universitätsklinik für Innere Medizin Graz

Graz, 8036, Austria
Valley Clinical Trials, Inc.

Northridge, California, 91325, United States
Valley Research

Fresno, California, 93720, United States
Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States
ViaCar Recherche Clinique Inc

Brossard, Quebec, J4Z 2K9, Canada
WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States
Wade Family Medicine

Bountiful, Utah, 84010, United States
Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States
Western Univ. Cnt for Studies in Fam Med

London, Ontario, N6G 2M1, Canada
Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada
Your Diabetes Endocrine Nutrition Group, Inc.

Mentor, Ohio, 44060, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.