Fact CheckerSign in

NCT06340854CompletedPhase 3

A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
412 (actual)
First submitted
26 Mar 2024
Start date
19 Apr 2024
Primary completion date
8 May 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06340854
EU CT number
2023-506084-34-00
EudraCT number
2023-506084-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 412
  • From 19 Apr 2024 to the primary completion date, 8 May 2025
  • 82 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any episodes 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.
  • 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.

Other illness

  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.

Lab values

  • 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).

Who the study is looking for

  • Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.
  • HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
  • Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
  • Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m\^2).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Viva Phoenix OOD
Coordinator of this site? Confirm its status
DobrichBulgariaCompleted
Alexandrovska University Hospital
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Medical Institute Ministry Of Interior
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaCompleted
Medcenter Nova Clinic Ltd.
Coordinator of this site? Confirm its status
VarnaBulgariaCompleted
Medical Center Berbatov Ltd.
Coordinator of this site? Confirm its status
YambolBulgariaCompleted
InnoDiab Forschung Gmbh
Coordinator of this site? Confirm its status
EssenGermanyCompleted
Institut fuer Diabetesforschung Muenster GmbH
Coordinator of this site? Confirm its status
MuensterGermanyCompleted
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Coordinator of this site? Confirm its status
MünsterGermanyCompleted
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Coordinator of this site? Confirm its status
Oldenburg in HolsteinGermanyCompleted
Institut für Diabetesforschung Osnabrück
Coordinator of this site? Confirm its status
OsnabrückGermanyCompleted
Zentrum für klinische Forschung Allgäu-Oberschwaben
Coordinator of this site? Confirm its status
WangenGermanyCompleted
Projectes Sanitaris I Socials S.A.
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario Basurto
Coordinator of this site? Confirm its status
BilbaoSpainCompleted
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainCompleted
Hospital Universitario Quironsalud Madrid
Coordinator of this site? Confirm its status
Pozuelo de AlarcónSpainCompleted
Swasthya Diabetes Care
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
Lifecare Hospital and Research Centre
Coordinator of this site? Confirm its status
BangaloreIndiaUnknown status
Belgaum Diabetes Centre
Coordinator of this site? Confirm its status
BelagaviIndiaUnknown status
Manipal Hospital, Old Airport Road, Bengaluru
Coordinator of this site? Confirm its status
BengaluruIndiaUnknown status
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
Coordinator of this site? Confirm its status
ChandigarhIndiaUnknown status
Malla Reddy Narayana Multispeciality Hospital
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Gandhi Hospital & Medical college
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
TOTALL Diabetes Hormone Institute
Coordinator of this site? Confirm its status
IndoreIndiaUnknown status
Amrita Institute of Medical Sciences & Research Centre
Coordinator of this site? Confirm its status
KochiIndiaUnknown status
Christian Medical College and Hospital
Coordinator of this site? Confirm its status
LudhianaIndiaUnknown status
Seth GS Medical College & KEM Hospital
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
Government Institute of Medical Sciences
Coordinator of this site? Confirm its status
NoidaIndiaUnknown status
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Coordinator of this site? Confirm its status
PuducherryIndiaUnknown status
Grant Medical Foundation Ruby Hall Clinic
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
Chellaram Diabetes Institute
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
FS Endocrine and diabetes Center
Coordinator of this site? Confirm its status
SaidābādIndiaUnknown status
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Coordinator of this site? Confirm its status
Fukuoka-shi, FukuokaJapanUnknown status
Heiwadai Hospital_Internal Medicine
Coordinator of this site? Confirm its status
MiyazakiJapanUnknown status
Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
Coordinator of this site? Confirm its status
Shinjuku-ku, TokyoJapanUnknown status
Oyama East Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TochigiJapanUnknown status
Noritake Clinic
Coordinator of this site? Confirm its status
Ushiku-shi, IbarakiJapanUnknown status
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
Coordinator of this site? Confirm its status
BialystokPolandCompleted
Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk
Coordinator of this site? Confirm its status
BiałystokPolandCompleted
Pratia S.A.
Coordinator of this site? Confirm its status
GdyniaPolandCompleted
Pratia S.A.
Coordinator of this site? Confirm its status
KatowicePolandCompleted
Uniwersytecki Szpital Kliniczny w Opolu
Coordinator of this site? Confirm its status
OpolePolandCompleted
Trialmed Sp. z o. o.
Coordinator of this site? Confirm its status
Piotrkow TrybunalskiPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Advanced Clinical Research, LLC
Coordinator of this site? Confirm its status
BayamónPuerto RicoUnknown status
Manati Ctr For Clin Research
Coordinator of this site? Confirm its status
ManatiPuerto RicoUnknown status
Amarillo Medical Specialists
Coordinator of this site? Confirm its status
AmarilloUnited StatesUnknown status
Velocity Clinical Res-Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Northeast Research Institute of Florida
Coordinator of this site? Confirm its status
Fleming IslandUnited StatesUnknown status
Diabetes and Thyroid Ctr of FW
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
Valley Research
Coordinator of this site? Confirm its status
FresnoUnited StatesUnknown status
PharmQuest Life Sciences LLC
Coordinator of this site? Confirm its status
GreensboroUnited StatesUnknown status
Advanced Investigative Medicine, Inc.
Coordinator of this site? Confirm its status
HawthorneUnited StatesUnknown status
PlanIt Research, PLLC
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Victorium Clinical Research
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Rocky Mountain Diab&Osteo Ctr
Coordinator of this site? Confirm its status
Idaho FallsUnited StatesUnknown status
Jefferson City Medical Group PC
Coordinator of this site? Confirm its status
Jefferson CityUnited StatesUnknown status
Scripps Whittier Diabetes Inst
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Palm Research Center Inc-Vegas
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Headlands Research CTR Lincoln
Coordinator of this site? Confirm its status
LincolnUnited StatesUnknown status
International Diabetes Center
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
South Broward Research LLC
Coordinator of this site? Confirm its status
MiramarUnited StatesUnknown status
Trial Management Associates
Coordinator of this site? Confirm its status
Myrtle BeachUnited StatesUnknown status
Southern NH Diabetes and Endo_Nashua
Coordinator of this site? Confirm its status
NashuaUnited StatesUnknown status
Capital Clin Res Ctr,LLC
Coordinator of this site? Confirm its status
OlympiaUnited StatesUnknown status
Univ of Nebraska Medical CTR
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Rainier Clin Res Ctr Inc
Coordinator of this site? Confirm its status
RentonUnited StatesUnknown status
Endo Res Solutions Inc
Coordinator of this site? Confirm its status
RoswellUnited StatesUnknown status
Chrysalis Clinical Research
Coordinator of this site? Confirm its status
St. GeorgeUnited StatesUnknown status
Cotton-Oneill Diabetes and End
Coordinator of this site? Confirm its status
TopekaUnited StatesUnknown status
Velocity Clinical_Valparaiso
Coordinator of this site? Confirm its status
ValparaisoUnited StatesUnknown status
Iowa Diab & Endo Res Center
Coordinator of this site? Confirm its status
West Des MoinesUnited StatesUnknown status
Accellacare - Wilmington
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status
Medi-Clinic Bloemfontein
Coordinator of this site? Confirm its status
BloemfonteinSouth AfricaUnknown status
Dr A Amod
Coordinator of this site? Confirm its status
DurbanSouth AfricaUnknown status
Dr MB Moosa's Practice
Coordinator of this site? Confirm its status
DurbanSouth AfricaUnknown status
Dr Mahesh Duki Research And Trial Site
Coordinator of this site? Confirm its status
DurbanSouth AfricaUnknown status
Centre for Diabetes
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
Hemant Makan
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
Dr Moosa's Rooms
Coordinator of this site? Confirm its status
LenasiaSouth AfricaUnknown status
Botho ke Bontle Health Services
Coordinator of this site? Confirm its status
PretoriaSouth AfricaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.