Clinical trial • Phase III • Endocrinology
Insulin icodec for Type 1 diabetes
Phase III trial of Insulin icodec for Type 1 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 1 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 25-04-2025
- First CTIS Authorization Date
- 18-08-2025
Trial design
Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen (insulin glargine) — once-daily (comparator).-controlled Phase III trial across 50 sites in Germany, Romania, Slovakia and others.
- Comparator
- Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen (insulin glargine) — once-daily (comparator).
- Target Sample Size
- 635
- Trial Duration For Participant
- 182
Eligibility
Recruits 635 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is obtained from adult participants using subject information and informed consent forms (PIIC main adult) provided per country; PIIC male partner and data protection forms are also available. No assent process for minors is described..
- Pregnancy Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent is obtained from adult participants using subject information and informed consent forms (PIIC main adult) provided per country; PIIC male partner and data protection forms are also available. No assent process for minors is described.
Inclusion criteria
- {"criterion_text":"- Diagnosed with type 1 diabetes mellitus ≥ 1 year before screening.\n- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.\n- HbA1c from 7.0–10.0% (53.0–85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.\n- Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement."}
Exclusion criteria
- {"criterion_text":"- Known or suspected hypersensitivity to study intervention(s) or related products.\n- Previous participation in this study. Participation is defined as signed informed consent.\n- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n- 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.\n- 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).\n- Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question.\n- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in HbA1c From baseline week 0 (V6) to week 26 (V32). Unit: %-point","definition_or_measurement_approach":"Change in HbA1c from baseline (week 0 / V6) to week 26 (V32); unit: %-point."}
Secondary endpoints
- {"endpoint_text":"- Change in time in range 3.9– 10.0 mmol/L (70–180 mg/dL). Using CGM system, Dexcom G7\n- Time spent <3.0 mmol/L (54 mg/dL). Using CGM system, Dexcom G7\n- Change in time spent >10.0 mmol/L (180 mg/dL). Using CGM system, Dexcom G7\n- Number of severe hypoglycaemic episodes (level 3)\n- Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter)\n- Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter) or severe hypoglycaemic episodes (level 3)\n- Number of CGM-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]). Using CGM system, Dexcom G7\n- Mean total weekly insulin dose\n- Change in body weight\n- Change in ITSQ total score\n- Change in ADAQ total score","definition_or_measurement_approach":"Endpoints measured as stated; CGM-based endpoints are measured using the Dexcom G7 CGM system where specified. Hypoglycaemic episodes level 2 are defined as < 3.0 mmol/L (54 mg/dL) and, where specified, confirmed by BG meter. ITSQ and ADAQ are patient-reported outcome total scores."}
Recruitment
- Planned Sample Size
- 635
- Recruitment Window Months
- 16
- Consent Approach
- Informed consent obtained from adult participants; subject information and informed consent forms (PIIC main adult) are provided per country. PIIC documents (including male partner and data protection forms) are available in the submission documents for English, German, Romanian, Polish and Slovak. No assent process for minors is described.
Methods
- Country-specific recruitment materials (posters, invitation letters, study leaflets) — documents available for Germany, Romania, Poland and Slovakia (e.g., Recruitment poster, Invitation Letter, Study leaflet).
- Provision of informed consent guides and subject information materials per country (subject information and informed consent forms / PIIC main adult documents).
- Recruitment via participating clinical sites (diabetes clinics, specialised centres) in each country (site list provided for Germany, Romania, Poland and Slovakia).
Geography
- Total Number Of Sites
- 50
- Total Number Of Participants
- 242
Germany
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 218
- Number Of Sites
- 16
- Number Of Participants
- 64
Sites
- Site Name
- MVZ DiaMedicum Bad Mergentheim GmbH
- Department Name
- Diabetespraxis Bad Mergentheim
- Contact Person Name
- Simon Vidal
- Contact Person Email
- Vidal@diabetespraxis.de
- Site Name
- Diabetes-Zentrum-Wilhelmsburg GbR
- Contact Person Name
- Peter Witzel
- Contact Person Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Site Name
- Zentrum für klinische Forschung Allgäu Oberschwaben
- Contact Person Name
- Joachim Sauter
- Contact Person Email
- joachim@dr-sauter-wangen.de
- Site Name
- Institut für Diabetesforschung Osnabrück
- Contact Person Name
- Markus Graf
- Contact Person Email
- mgraf@dzos.de
- Site Name
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
- Contact Person Name
- Uta Dorothea Stephan
- Contact Person Email
- stephan@mvz-bahnhof-spandau.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Universitätsklinikum Carl Gustav Carus an der TU Dresden. Med. Klinik und Poliklinik III
- Contact Person Name
- Nikolaos Perakakis
- Contact Person Email
- nikolaos.perakakis@uniklinikum-dresden.de
- Site Name
- MVZ Diabeteszentrum Dr. Tews GmbH
- Contact Person Name
- Dietrich Tews
- Contact Person Email
- dietrich.tews@tews-diabetes.de
- Site Name
- Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
- Contact Person Name
- Pavel-Marcel Serban
- Contact Person Email
- praxis.serban@t-online.de
- Site Name
- DSP Diabetes- und Stoffwechselpraxis Bochum
- Contact Person Name
- Babette Lorra
- Contact Person Email
- b.lorra@dsp-bochum.de
- Site Name
- InnoDiab Forschung GmbH
- Contact Person Name
- Helga Zeller
- Contact Person Email
- helga.zeller@innodiab.de
- Site Name
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
- Department Name
- Praxis Dr. Keuthage, MedicalCenter am Clemenshospital
- Contact Person Name
- Winfried Keuthage
- Contact Person Email
- keuthage@diabetes-praxis-muenster.de
- Site Name
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
- Contact Person Name
- Susanne Reger-Tan
- Contact Person Email
- sreger-tan@hdz-nrw.de
- Site Name
- Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
- Contact Person Name
- Thorsten Koch
- Contact Person Email
- t.koch@hamburg-diabetes.de
- Site Name
- Diabeteszentrum Hamburg West
- Contact Person Name
- Dominik Dahl
- Contact Person Email
- dr.dahl@dzhw.de
- Site Name
- Die Praxis am Ludwigsplatz
- Contact Person Name
- Hans-Peter Kempe
- Contact Person Email
- kempe@kempe-stemler.de
- Site Name
- Zentrum für klinische Studien Alexander Segner
- Contact Person Name
- Alexander Segner
- Contact Person Email
- alexander.segner@zks-igb.de
Romania
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 278
- Number Of Sites
- 14
- Number Of Participants
- 53
Sites
- Site Name
- Minimed S.R.L.
- Contact Person Name
- Roxana Barbu
- Contact Person Email
- dr.roxanabarbu@hotmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
- Department Name
- Diabetes
- Contact Person Name
- Doina Catrinoiu
- Contact Person Email
- dcatrinoiu@gmail.com
- Site Name
- Nutrilife S.R.L.
- Contact Person Name
- Marlena Pascu
- Contact Person Email
- marlena.pascu@nutrilife.ro
- Site Name
- Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
- Department Name
- Diabetes
- Contact Person Name
- Claudiu Cobuz
- Contact Person Email
- cobuzclaudiu@yahoo.com
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Contact Person Name
- Valentina Neacsu
- Contact Person Email
- vneacsu@neomed.org
- Site Name
- Clinica Korall S.R.L.
- Contact Person Name
- Adriana Filimon
- Contact Person Email
- adriana_teaca@yahoo.com
- Site Name
- Diabmed Dr. Popescu Alexandrina S.R.L.
- Contact Person Name
- Alexandrina Popescu
- Contact Person Email
- diabmedph@yahoo.com
- Site Name
- Sc Cmi Dr. Pletea Noemi S.R.L.
- Contact Person Name
- Noemi Pletea
- Contact Person Email
- pleteanoemi@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Sibiu
- Department Name
- Diabetes
- Contact Person Name
- Alina Mot
- Contact Person Email
- alina71mot@gmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- Diabetes
- Contact Person Name
- Adrian Vlad
- Contact Person Email
- vladrian@hotmail.com
- Site Name
- Diamed Obesity S.R.L.
- Contact Person Name
- Magdalena Morosanu
- Contact Person Email
- magda_m28@yahoo.com
- Site Name
- Dianutrilife Medica S.R.L.
- Contact Person Name
- Bogdan Popa
- Contact Person Email
- bogdan.popa@dianutrilife.ro
- Site Name
- Top Diabet S.R.L.
- Contact Person Name
- Ionela Mihaela Vladu
- Contact Person Email
- mihmitzu@yahoo.com
- Site Name
- Diabs&Nutricare S.R.L.
- Contact Person Name
- Cosmin Pena
- Contact Person Email
- dr.pena76@gmail.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 209
- Number Of Sites
- 7
- Number Of Participants
- 37
Sites
- Site Name
- Diabint s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Kristina Vyslan
- Contact Person Email
- radolcova.kristina@gmail.com
- Site Name
- Dioli s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Olga Bobelova
- Contact Person Email
- dr.bobelova.dia@gmail.com
- Site Name
- DIADAN s.r.o. Kosice
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Dana Solcova
- Contact Person Email
- dankasolc@gmail.com
- Site Name
- Medispektrum s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Adriana Ilavska
- Contact Person Email
- ambulancia@medispektrum.com
- Site Name
- Human-Care s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Viera Donicova
- Contact Person Email
- diabetolog@gmail.com
- Site Name
- Diabeda s.r.o.
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Branislav Vohnout
- Contact Person Email
- diabetologiaraca@gmail.com
- Site Name
- Medispektrum s.r.o. (additional site listed)
- Department Name
- Ambulancia diabetologie a poruch latkovej premeny a vyzivy
- Contact Person Name
- Adriana Ilavska
- Contact Person Email
- ambulancia@medispektrum.com
Poland
- Earliest CTIS Part Ii Submission Date
- 15-07-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 216
- Number Of Sites
- 13
- Number Of Participants
- 88
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Chorób Wewnętrznych, Endokrynologii i Diabetologii
- Contact Person Name
- Olga Turowska
- Contact Person Email
- olga.turowska@pimmswia.gov.pl
- Site Name
- Zanamed Medical Clinic Sp. z o.o.
- Contact Person Name
- Anna Tochman-Gawda
- Contact Person Email
- anna.tg@op.pl
- Site Name
- Zespół Wojewódzkich Przychodni Specjalistycznych w Katowicach
- Department Name
- Poradnia dla Chorych na Cukrzycę
- Contact Person Name
- Krzysztof Strojek
- Contact Person Email
- kstrojek@sum.edu.pl
- Site Name
- Formed 2 Sp. z o.o.
- Contact Person Name
- Grzegorz Betlej
- Contact Person Email
- grzegorz.betlej@nzozformed2.pl
- Site Name
- GABINET LEKARSKI MALGORZATA SARYUSZ-WOLSKA
- Contact Person Name
- Katarzyna Cypryk
- Contact Person Email
- kcypryk@mp.pl
- Site Name
- Irmed Klimkiewicz Rudziewicz-Kowalska-Kowalska sp. j.
- Contact Person Name
- Krzysztof Brucki-Stempkowski
- Contact Person Email
- diabetolog@ir-med.pl
- Site Name
- Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
- Contact Person Name
- Barbara Sorobka
- Contact Person Email
- b.sorobka@wp.pl
- Site Name
- Reumed Sp. z o.o.
- Contact Person Name
- Agnieszka Zwolak
- Contact Person Email
- zwolakag@wp.pl
- Site Name
- Etg Zamosc Sp. z o.o.
- Contact Person Name
- Katarzyna Wojcik
- Contact Person Email
- zamosc@etg-network.com
- Site Name
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
- Contact Person Name
- Joanna Mirocka
- Contact Person Email
- jmirocka@gmail.com
- Site Name
- Metabolica Sp. z o.o.
- Contact Person Name
- Robert Witek
- Contact Person Email
- robertwitek1@gmail.com
- Site Name
- Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
- Department Name
- Poradnia Internistyczna
- Contact Person Name
- Dorota Zozulinska-Ziolkiewicz
- Contact Person Email
- zozula@box43.pl
- Site Name
- Centrum Medyczne Intercor Sp. z o.o.
- Contact Person Name
- Roman Junik
- Contact Person Email
- intercor@farmepo.com
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Q Squared Solutions Limited
- Responsibilities
- code:4
- Name
- 4G Clinical B.V.
- Responsibilities
- RTSM supplier
- Name
- Celerion Switzerland AG
- Responsibilities
- Special Laboratory: For antibodies and PK
Third parties
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Denmark","full_name":"HCL Technologies Denmark Aps","duties_or_roles":"eDiary helpdesk","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Danoffice IT ApS","duties_or_roles":"IT Hardware & Logistics supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Diabetes Care Inc.","duties_or_roles":"BG meter supplier","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Precision Digital Health Inc.","duties_or_roles":"Continuous Glucose Monitoring (CGM) supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"Global Safety Database supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"CRF supplier","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM supplier","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"Special Laboratory: For antibodies and PK","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 (marketing authorisation, EU; marketingAuthNumber EU/1/24/1815/009)
- Frequency
- Once-weekly
- Investigational Product Name
- Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
- Active Substance
- Insulin glargine
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation, EU; marketingAuthNumber EU/1/00/134/033)
- Frequency
- Once-daily
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.