A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes
Recruiting · NCT07112339 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
Basal insulin analoguesInsulin icodec
What this trial is about
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
- 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.
- Need of intensification with basal insulin, as indicated at the discretion of the investigator.
- Recorded HbA1c value ≥7% within the last 90 days prior to randomization.
Exclusion criteria
- 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 child-bearing potential and not using adequate contraceptive method.
- Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
- Any disorder which in the investigator's opinion might jeopardize participant's safety.
Where it is running
60 locations listed.
- Diabetespraxis Mergentheim - Bad Mergentheim, Germany
- Praxis Dr. Stephan Scharla - Bad Reichenhall, Germany
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR - Berlin, Germany
- Studiengesellschaft Dres. Könemann/Steinmann GbR - Bünde, Germany
- Università degli studi G. D'Annunzio Chieti Pescara - CAST - Chieti Scalo, Italy
- Diabetologische Schwerpunktpraxis Daaden - Daaden, Germany
- Diabeteszentrum-Do Dres. K U. Ch. Busch GbR - Dortmund, Germany
- Studienzentrum Dr. Faulmann GbR Dresden - Dresden, Germany
- MVZ Hausärzte Großenbaum GmbH Duisburg - Duisburg, Germany
- Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach - Eisenach, Germany
- MVZ Contilia GmbH - Essen, Germany
- Praxis am Markt Dr. Becker - Essen, Germany
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien - Fulda, Germany
- Diabetes-Zentrum-Wilhelmsburg GbR - Hamburg, Germany
- Mesut Durmaz, Hof - Hof, Germany
- Praxisgemeinschaft Jerichow - Jerichow, Germany
- Familienmedizinisches Zentrum Radowsky - Leipzig, Germany
- Praxis Am Oberen Tor - Dr. Simon-Wagner - Lichtenfels, Germany
- Diabeteszentrum Ludwigsburg - Ludwigsburg, Germany
- Institut für Diabetesforschung Osnabrück - Osnabrück, Germany
- ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim - Pohlheim, Germany
- Recherche Clinique Sigma Inc. - Québec, Canada
- Diex Recherche Quebec - Québec, Canada
- Centre de Recherche Saint-Louis - Québec, Canada
- Alpha Recherche Clinique - Lebourgneuf - Québec, Canada
- AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna - Ravenna, Italy
- Azienda Ospealiero Universitaria Policlinico Umberto I - Roma, Italy
- Hegau-Bodensee-Klinikum Singen - Singen, Germany
- Dr. Schmidt-Reinwald Astrid, Trier - Trier, Germany
- Centricity Research Calgary Endocrinology - Calgary, Alberta, Canada
- Alta Clinical Research at Hermitage Medicentre - Edmonton, Alberta, Canada
- A.O.U. Consorziale Policlinico di Bari - Bari, BA, Italy
- Versdias - Diabetologikum Amberg - Amberg, Bavaria, Germany
- Fraser Clinical Trials Inc. - New Westminster, British Columbia, Canada
- Azienda Ospedaliero Universitaria Renato Dulbecco - Mater Domini - Catanzaro, Calabria, Italy
- AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo - Naples, Campania, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche - Rome, Lazio, Italy
- ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia - Milan, Lombardy, Italy
- Winnipeg Clinic - Winnipeg, Manitoba, Canada
- G.A. Research Associates Ltd. - Moncton, New Brunswick, Canada
- Centricity Research Brampton Endocrinology - Brampton, Ontario, Canada
- Centricity Clinical Research Burlington - Burlington, Ontario, Canada
- Centricity Research Vaughn Endocrinology - Concord, Ontario, Canada
- Medical Trust Clinics, Inc. - Courtice, Ontario, Canada
- Centricity Research Etobicoke Endocrinology - Etobicoke, Ontario, Canada
- Janik Research - Greater Sudbury, Ontario, Canada
- Hamilton Medical Research Group - Hamilton, Ontario, Canada
- St. Josephs Health Care - London, Ontario, Canada
- Western Univ. Cnt for Studies in Fam Med - London, Ontario, Canada
- Malton Medical Clinic - Mississauga, Ontario, Canada
- Centricity Research Ottawa LMC - Nepean, Ontario, Canada
- The Ottawa Hospital_Riverside - Ottawa, Ontario, Canada
- Bluewater Clin Res Group Inc - Sarnia, Ontario, Canada
- Sewa Ram Singal Medicine Professional Corp - Toronto, Ontario, Canada
- Centricity Research Toronto - Toronto, Ontario, Canada
- Centricity Research Toronto Manna Multispec - Toronto, Ontario, Canada
- Diex Recherche Joliette - Joliette, Quebec, Canada
- Alpha Recherche Clinique - Clinique de Levis - Lévis, Quebec, Canada
- Centricity Research Mirabel - Mirabel, Quebec, Canada
- Centre hospitalier de l'Universite de Montreal - Montreal, Quebec, Canada
Showing 60 of 75 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →