Clinical trial • Endocrinology
INSULIN ICODEC for Type 2 diabetes
Clinical trial of INSULIN ICODEC for Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 05-09-2025
Trial design
Randomised, once-daily basal insulin analogues at the discretion of the investigator (comparators include insulin detemir (levemir), insulin glargine (lantus / toujeo), and insulin degludec (tresiba)); doses not specified in the provided record; schedule: once-daily basal insulin.-controlled trial in Germany, Italy.
- Randomised
- Yes
- Comparator
- Once-daily basal insulin analogues at the discretion of the investigator (comparators include insulin detemir (Levemir), insulin glargine (Lantus / Toujeo), and insulin degludec (Tresiba)); doses not specified in the provided record; schedule: once-daily basal insulin.
- Real World Control
- Yes
- Target Sample Size
- 306
- Trial Duration For Participant
- 364
Eligibility
Recruits 306 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants. Subject information and informed consent forms for adults, partner and pregnancy-specific information are provided (documents available for Germany and Italy). No assent or special consent handling for minors is indicated..
- Pregnancy Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is required from adult participants. Subject information and informed consent forms for adults, partner and pregnancy-specific information are provided (documents available for Germany and Italy). No assent or special consent handling for minors is indicated.
Inclusion criteria
- {"criterion_text":"- Diagnosed with T2D ≥180 days prior to the day of screening."}
- {"criterion_text":"- Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening: Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist."}
- {"criterion_text":"- Need of intensification with basal insulin, as indicated at the discretion of the investigator."}
- {"criterion_text":"- Recorded HbA1c value ≥7% within the last 90 days prior to randomisation."}
Exclusion criteria
- {"criterion_text":"- Known or suspected hypersensitivity to study intervention(s) or related products."}
- {"criterion_text":"- Previous participation in this study. Participation is defined as signed informed consent."}
- {"criterion_text":"- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method."}
- {"criterion_text":"- Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening."}
- {"criterion_text":"- Any disorder which in the investigator’s opinion might jeopardise participant’s safety."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in HbA1c from baseline week 0 (V2) to week 52 (V6).","definition_or_measurement_approach":"Change in HbA1c from baseline (week 0) to week 52; primary analysis compares difference in change from baseline in HbA1c between once-weekly insulin icodec and once-daily basal insulin analogues after 52 weeks (non-inferiority limit 0.3% as specified in main objective)."}
Secondary endpoints
- {"endpoint_text":"- Adelphi Adherence Questionnaire (ADAQ©) At week 52 (V6).","definition_or_measurement_approach":"Patient-reported adherence measured using the Adelphi Adherence Questionnaire (ADAQ©) at week 52."}
- {"endpoint_text":"- Change in DTSQs in total treatment satisfaction from baseline week 0 (V2) to week 52 (V6).","definition_or_measurement_approach":"Change from baseline to week 52 in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) total treatment satisfaction score."}
- {"endpoint_text":"- TRIM-D compliance domain at week 52 (V6).","definition_or_measurement_approach":"Measurement using the Treatment Related Impact Measure - Diabetes (TRIM-D) compliance domain at week 52."}
- {"endpoint_text":"- TRIM-D treatment burden domain at week 52 (V6).","definition_or_measurement_approach":"Measurement using the TRIM-D treatment burden domain at week 52."}
- {"endpoint_text":"- Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 52 (V6).","definition_or_measurement_approach":"Count of level 3 (severe) hypoglycaemic episodes occurring from baseline to week 52."}
- {"endpoint_text":"- Mean weekly basal insulin dose from week 50 to week 52 (V6).","definition_or_measurement_approach":"Mean weekly basal insulin dose averaged over weeks 50–52 (week 50 to week 52)."}
- {"endpoint_text":"- Participant achieved individualised HbA1c target at week 52 (V6).","definition_or_measurement_approach":"Proportion of participants achieving their individualised HbA1c target at week 52."}
Recruitment
- Planned Sample Size
- 306
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms are provided (documents available for Germany and Italy: adult main forms, male partner form, pregnancy-specific form). Consent materials are available in German and Italian as indicated by the submitted subject information and consent form documents. No assent procedures for minors are indicated.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 204
Germany
- Earliest CTIS Part Ii Submission Date
- 19-08-2025
- Latest Decision Or Authorization Date
- 05-09-2025
- Processing Time Days
- 17
- Number Of Sites
- 23
- Number Of Participants
- 130
Sites
- Site Name
- MVZ im Altstadt-Carree Fulda GmbH
- Department Name
- Zentrum für klinische Studien
- Principal Investigator Name
- Jörg Simon
- Principal Investigator Email
- info@schwerpunkt-praxis.de
- Contact Person Name
- Jörg Simon
- Contact Person Email
- info@schwerpunkt-praxis.de
- Site Name
- Praxisgemeinschaft Jerichow Schulze
- Principal Investigator Name
- Jörg Schulze
- Principal Investigator Email
- joerg.schulze@arztpraxis-jerichow.de
- Contact Person Name
- Jörg Schulze
- Contact Person Email
- joerg.schulze@arztpraxis-jerichow.de
- Site Name
- Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
- Department Name
- Schwerpunktpraxis Dres. Klaus Busch und Christian Busch/Christoph Cramer
- Principal Investigator Name
- Christian Busch
- Principal Investigator Email
- christian.busch@diabeteszentrum-doc.de
- Contact Person Name
- Christian Busch
- Contact Person Email
- christian.busch@diabeteszentrum-doc.de
- Site Name
- Diabetes-Zentrum-Wilhelmsburg GbR
- Principal Investigator Name
- Peter Witzel
- Principal Investigator Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Contact Person Name
- Peter Witzel
- Contact Person Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Site Name
- Institut für Diabetesforschung Osnabrück
- Principal Investigator Name
- Markus Graf
- Principal Investigator Email
- mgraf@dzos.de
- Contact Person Name
- Markus Graf
- Contact Person Email
- mgraf@dzos.de
- Site Name
- Diabeteszentrum Ludwigsburg
- Principal Investigator Name
- Suzanne Milan
- Principal Investigator Email
- dr.suzanne.milan@gmx.de
- Contact Person Name
- Suzanne Milan
- Contact Person Email
- dr.suzanne.milan@gmx.de
- Site Name
- Diabetologische Schwerpunktpraxis Daaden
- Principal Investigator Name
- Dirk Nonhoff
- Principal Investigator Email
- dirk.nonhoff@t-online.de
- Contact Person Name
- Dirk Nonhoff
- Contact Person Email
- dirk.nonhoff@t-online.de
- Site Name
- Studienzentrum Dr. Faulmann GbR
- Principal Investigator Name
- Frank Schaper
- Principal Investigator Email
- fschaper@studienzentrum-dd.de
- Contact Person Name
- Frank Schaper
- Contact Person Email
- fschaper@studienzentrum-dd.de
- Site Name
- Centrum Fuer Diabetologie Und Allgemeinmedizin
- Department Name
- ceda
- Principal Investigator Name
- Cornelia Marck
- Principal Investigator Email
- cpmarck@t-online.de
- Contact Person Name
- Cornelia Marck
- Contact Person Email
- cpmarck@t-online.de
- Site Name
- Praxis Dr. Stephan Scharla
- Principal Investigator Name
- Stephan Scharla
- Principal Investigator Email
- sscharla@gmx.de
- Contact Person Name
- Stephan Scharla
- Contact Person Email
- sscharla@gmx.de
- Site Name
- Studiengesellschaft Drs Könemann / Steinmann
- Department Name
- Wilhelmstraße 25-27
- Principal Investigator Name
- Kai Koenemann
- Principal Investigator Email
- dr.koenemann@diabetes-buende.de
- Contact Person Name
- Kai Koenemann
- Contact Person Email
- dr.koenemann@diabetes-buende.de
- Site Name
- Versdias GmbH
- Department Name
- Diabetologikum Amberg-Sulzbach
- Principal Investigator Name
- Ulrich-Michael Aigner
- Principal Investigator Email
- u.aigner@diabetes-as.de
- Contact Person Name
- Ulrich-Michael Aigner
- Contact Person Email
- u.aigner@diabetes-as.de
- Site Name
- Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum
- Principal Investigator Name
- Mesut Durmaz
- Principal Investigator Email
- mesut@durmaz-hof.de
- Contact Person Name
- Mesut Durmaz
- Contact Person Email
- mesut@durmaz-hof.de
- Site Name
- Familienmedizinisches Zentrum Radowsky
- Department Name
- FMZ Radowsky - Studienzentrum
- Principal Investigator Name
- Frank Radowsky
- Principal Investigator Email
- fr.studienzentrum.fmz@gmail.com
- Contact Person Name
- Frank Radowsky
- Contact Person Email
- fr.studienzentrum.fmz@gmail.com
- Site Name
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
- Principal Investigator Name
- Uta Dorothea Stephan
- Principal Investigator Email
- stephan@mvz-bahnhof-spandau.de
- Contact Person Name
- Uta Dorothea Stephan
- Contact Person Email
- stephan@mvz-bahnhof-spandau.de
- Site Name
- Gesundheitsverbund Landkreis Konstanz gGmbH
- Department Name
- Hegau-Bodensee-Klinikum Singen GmbH, Studienzentrum Hegau-Bodensee
- Principal Investigator Name
- Marc Kollum
- Principal Investigator Email
- Marc.kollum@glkn.de
- Contact Person Name
- Marc Kollum
- Contact Person Email
- Marc.kollum@glkn.de
- Site Name
- Praxis Dr. Astrid Schmidt-Reinwald
- Principal Investigator Name
- Astrid Schmidt-Reinwald
- Principal Investigator Email
- schmidt-reinwald@gmx.de
- Contact Person Name
- Astrid Schmidt-Reinwald
- Contact Person Email
- schmidt-reinwald@gmx.de
- Site Name
- Praxis Am Oberen Tor
- Department Name
- Praxis Dr. Simon-Wagner
- Principal Investigator Name
- Ilka Simon-Wagner
- Principal Investigator Email
- kontakt@dr-simon-wagner.de
- Contact Person Name
- Ilka Simon-Wagner
- Contact Person Email
- kontakt@dr-simon-wagner.de
- Site Name
- MVZ Contilia GmbH - Studienzentrum Diabetologie
- Principal Investigator Name
- Anna Trocha
- Principal Investigator Email
- a.trocha@contilia.de
- Contact Person Name
- Anna Trocha
- Contact Person Email
- a.trocha@contilia.de
- Site Name
- Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
- Principal Investigator Name
- Pavel-Marcel Serban
- Principal Investigator Email
- praxis.serban@t-online.de
- Contact Person Name
- Pavel-Marcel Serban
- Contact Person Email
- praxis.serban@t-online.de
- Site Name
- Praxis am Markt Dr. Becker
- Principal Investigator Name
- Bernd Becker
- Principal Investigator Email
- dr.b.becker-essen@t-online.de
- Contact Person Name
- Bernd Becker
- Contact Person Email
- dr.b.becker-essen@t-online.de
- Site Name
- MVZ DiaMedicum Bad Mergentheim GmbH
- Department Name
- Diabetespraxis Bad Mergentheim
- Principal Investigator Name
- Simon Vidal
- Principal Investigator Email
- Vidal@diabetespraxis.de
- Contact Person Name
- Simon Vidal
- Contact Person Email
- Vidal@diabetespraxis.de
- Site Name
- MVZ Hausärzte Großenbaum GmbH
- Principal Investigator Name
- Matthias Künster
- Principal Investigator Email
- kuenster@hausaerzte-grossenbaum.de
- Contact Person Name
- Matthias Künster
- Contact Person Email
- kuenster@hausaerzte-grossenbaum.de
Italy
- Earliest CTIS Part Ii Submission Date
- 28-11-2025
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 45
- Number Of Sites
- 13
- Number Of Participants
- 74
Sites
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Principal Investigator Name
- Edoardo Mannucci
- Principal Investigator Email
- edoardo.mannucci@unifi.it
- Contact Person Name
- Edoardo Mannucci
- Contact Person Email
- edoardo.mannucci@unifi.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Principal Investigator Name
- Paolo Di Bartolo
- Principal Investigator Email
- paolo.dibartolo@auslromagna.it
- Contact Person Name
- Paolo Di Bartolo
- Contact Person Email
- paolo.dibartolo@auslromagna.it
- Site Name
- Azienda Ospedaliera Universitaria Gaetano Martino Messina
- Principal Investigator Name
- Giuseppina Giuseppina Russo
- Principal Investigator Email
- girusso@unime.it
- Contact Person Name
- Giuseppina Giuseppina Russo
- Contact Person Email
- girusso@unime.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Principal Investigator Name
- Francesca Porcellati
- Principal Investigator Email
- francesca.porcellati@unipg.it
- Contact Person Name
- Francesca Porcellati
- Contact Person Email
- francesca.porcellati@unipg.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Principal Investigator Name
- Andrea Giaccari
- Principal Investigator Email
- andrea.giaccari@unicatt.it
- Contact Person Name
- Andrea Giaccari
- Contact Person Email
- andrea.giaccari@unicatt.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Principal Investigator Name
- Manfredi Rizzo
- Principal Investigator Email
- manfredi.rizzo@unipa.it
- Contact Person Name
- Manfredi Rizzo
- Contact Person Email
- manfredi.rizzo@unipa.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Principal Investigator Name
- Katherine Esposito
- Principal Investigator Email
- katherine.esposito@unina2.it
- Contact Person Name
- Katherine Esposito
- Contact Person Email
- katherine.esposito@unina2.it
- Site Name
- University Of Bari Aldo Moro
- Principal Investigator Name
- Francesco Giorgino
- Principal Investigator Email
- francesco.giorgino@uniba.it
- Contact Person Name
- Francesco Giorgino
- Contact Person Email
- francesco.giorgino@uniba.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Principal Investigator Name
- Raffaella Buzzetti
- Principal Investigator Email
- raffaella.buzzetti@uniroma1.it
- Contact Person Name
- Raffaella Buzzetti
- Contact Person Email
- raffaella.buzzetti@uniroma1.it
- Site Name
- ASST Fatebenefratelli Sacco
- Principal Investigator Name
- Paolo Fiorina
- Principal Investigator Email
- paolo.fiorina@asst-fbf-sacco.it
- Contact Person Name
- Paolo Fiorina
- Contact Person Email
- paolo.fiorina@asst-fbf-sacco.it
- Site Name
- Azienda Ospedaliero Universitaria Renato Dulbecco
- Principal Investigator Name
- Concetta Irace
- Principal Investigator Email
- irace@unicz.it
- Contact Person Name
- Concetta Irace
- Contact Person Email
- irace@unicz.it
- Site Name
- Universita' Degli Studi G. D'Annunzio Di Chieti
- Principal Investigator Name
- Maria Pompea Antonia Baldassarre
- Principal Investigator Email
- maria.baldassarre@unich.it
- Contact Person Name
- Maria Pompea Antonia Baldassarre
- Contact Person Email
- maria.baldassarre@unich.it
- Site Name
- Azienda Sanitaria Territoriale Di Fermo
- Principal Investigator Name
- Paola Pantanetti
- Principal Investigator Email
- paola.pantanetti@sanita.marche.it
- Contact Person Name
- Paola Pantanetti
- Contact Person Email
- paola.pantanetti@sanita.marche.it
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- 4G Clinical B.V.
- Responsibilities
- RTSM
Third parties
- {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Awiqli 700 units/mL solution for injection in pre-filled pen
- Active Substance
- INSULIN ICODEC
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once-weekly (per study design: once-weekly insulin icodec)
- Investigational Product Name
- Levemir FlexPen 100 units/ml solution for injection in pre-filled pen
- Active Substance
- INSULIN DETEMIR
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once-daily (basal insulin, per comparator description)
- Investigational Product Name
- Lantus 100 units/ml solution for injection (vial/cartridge/pen formulations)
- Active Substance
- INSULIN GLARGINE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once-daily (basal insulin, per comparator description)
- Investigational Product Name
- Toujeo 300 units/ml solution for injection in a pre-filled pen/DoubleStar/SoloStar
- Active Substance
- INSULIN GLARGINE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once-daily (basal insulin, per comparator description)
- Investigational Product Name
- Tresiba 100/200 units/mL solution for injection (FlexTouch / Penfill)
- Active Substance
- INSULIN DEGLUDEC
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Frequency
- Once-daily (basal insulin, per comparator description)
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