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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1302-4943 | Other Identifier | World Health Organization (WHO) | |
| 2024-520068-32 | Other Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec | Experimental | Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec. |
|
| Basal insulin analogues | Active Comparator | Participants will receive once daily s.c. injection of basal insulin analogues. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Insulin icodec will be administered as subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as %-point. | From baseline week 0 to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Adelphi Adherence Questionnaire (ADAQ©) | Measured as Score. The ADAQ© score is calculated as the mean of 11 individual items, each rated on a scale from 0 to 4. To obtain the mean score, at least 8 of these items must be answered. A lower score indicates greater adherence. | At week 52 |
| Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centricity Research Calgary Endocrinology | Recruiting | Calgary | Alberta | T2H 2G4 | Canada | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Basal insulin analogues |
| Drug |
Basal insulin analogues will be administered as subcutaneous injection. |
|
Measured as Score of 0-36. DTSQs score ranges from 0 to 36, based on 6 items that are each rated on a scale of 0 to 6. A higher score reflects greater satisfaction with the treatment received. |
| From baseline week 0 to week 52 |
| Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain | Measured as Score of 4-20.The score ranges from 4 to 20, based on 4 items rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate better compliance. | At week 52 |
| Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain | Measured as Score of 6-30. The score ranges from 6 to 30, derived from 6 items each rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate less treatment burden. | At week 52 |
| Number of severe hypoglycaemic episodes (level 3) | Measured as Number of episodes. | From baseline week 0 to week 52 |
| Mean weekly basal insulin dose | Measures in Units. | From week 50 to week 52 |
| Participant achieved individualised HbA1c target | Reported as Yes or No. | At week 52 |
| Alta Clinical Research at Hermitage Medicentre |
| Recruiting |
| Edmonton |
| Alberta |
| T5A 4L8 |
| Canada |
| Fraser Clinical Trials Inc. | Recruiting | New Westminster | British Columbia | V3L 3W4 | Canada |
| Winnipeg Clinic | Recruiting | Winnipeg | Manitoba | R3C 0N2 | Canada |
| G.A. Research Associates Ltd. | Recruiting | Moncton | New Brunswick | E1G 1A7 | Canada |
| Centricity Research Brampton Endocrinology | Recruiting | Brampton | Ontario | L6S 0C6 | Canada |
| Centricity Clinical Research Burlington | Completed | Burlington | Ontario | L7M 4Y1 | Canada |
| Centricity Research Vaughn Endocrinology | Recruiting | Concord | Ontario | L4K 4M2 | Canada |
| Medical Trust Clinics, Inc. | Completed | Courtice | Ontario | L1E2J5 | Canada |
| Centricity Research Etobicoke Endocrinology | Recruiting | Etobicoke | Ontario | M9R 4E1 | Canada |
| Janik Research | Recruiting | Greater Sudbury | Ontario | P3C 1SB | Canada |
| Premier Clinical Trial Research Network (PCTRN) | Recruiting | Hamilton | Ontario | L8M 1K7 | Canada |
| St. Josephs Health Care | Recruiting | London | Ontario | N6A 4V2 | Canada |
| Western Univ. Cnt for Studies in Fam Med | Recruiting | London | Ontario | N6G 2M1 | Canada |
| Malton Medical Clinic | Completed | Mississauga | Ontario | L4V 1P1 | Canada |
| Centricity Research Ottawa LMC | Recruiting | Nepean | Ontario | K2J 0V2 | Canada |
| The Ottawa Hospital_Riverside | Not yet recruiting | Ottawa | Ontario | K1H7W9 | Canada |
| Bluewater Clin Res Group Inc | Completed | Sarnia | Ontario | N7T 4X3 | Canada |
| Sewa Ram Singal Medicine Professional Corp | Recruiting | Toronto | Ontario | M3N 2V6 | Canada |
| Centricity Research Toronto | Recruiting | Toronto | Ontario | M4G 3E8 | Canada |
| Centricity Research Toronto Manna Multispec | Completed | Toronto | Ontario | M9W 4L6 | Canada |
| Diex Recherche Joliette | Recruiting | Joliette | Quebec | J6E 6A9 | Canada |
| Alpha Recherche Clinique - Clinique de Levis | Recruiting | Lévis | Quebec | G6V 0C9 | Canada |
| Centricity Research Mirabel | Recruiting | Mirabel | Quebec | J7J 2K8 | Canada |
| Centre hospitalier de l'Universite de Montreal | Not yet recruiting | Montreal | Quebec | H2W 1R7 | Canada |
| McGill University Health Centre | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Applied Medical Informatics Research | Recruiting | Montreal | Quebec | H4A 3T2 | Canada |
| Clinique Endocrinologie OASIS. | Recruiting | Montreal | Quebec | H4J 1E3 | Canada |
| Centricity Res Pointe-Claire | Recruiting | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| ALPHA Recherche Clinique | Completed | Québec | Quebec | G3K 2P8 | Canada |
| Diex Recherche Sherbrooke | Completed | Sherbrooke | Quebec | J1E 0N8 | Canada |
| Centre de Recherche Saint-Louis | Recruiting | Sherbrooke | Quebec | J1G 1X9 | Canada |
| Ctr de Med Metab de Lanaudiere | Recruiting | Terrebonne | Quebec | J6X 4P7 | Canada |
| Diex Recherche Trois-Rivieres | Recruiting | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Diex Recherche Victoriaville | Recruiting | Victoriaville | Quebec | G6P 3Z8 | Canada |
| Recherche Clinique Sigma Inc. | Recruiting | Québec | G1G 5X1 | Canada |
| Diex Recherche Quebec | Recruiting | Québec | G1V 4T3 | Canada |
| Centre de Recherche Saint-Louis | Recruiting | Québec | G1W 4R4 | Canada |
| Alpha Recherche Clinique - Lebourgneuf | Recruiting | Québec | G2J 0C4 | Canada |
| Versdias - Diabetologikum Amberg | Recruiting | Amberg | Bavaria | 92224 | Germany |
| Diabetespraxis Mergentheim | Recruiting | Bad Mergentheim | 97980 | Germany |
| Praxis Dr. Stephan Scharla | Not yet recruiting | Bad Reichenhall | 83435 | Germany |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR | Recruiting | Berlin | 13597 | Germany |
| Studiengesellschaft Dres. Könemann/Steinmann GbR | Recruiting | Bünde | 32257 | Germany |
| Diabetologische Schwerpunktpraxis Daaden | Recruiting | Daaden | 57567 | Germany |
| Diabeteszentrum-Do Dres. K U. Ch. Busch GbR | Recruiting | Dortmund | 44137 | Germany |
| Studienzentrum Dr. Faulmann GbR Dresden | Recruiting | Dresden | 01279 | Germany |
| MVZ Hausärzte Großenbaum GmbH Duisburg | Recruiting | Duisburg | 47269 | Germany |
| Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach | Completed | Eisenach | 99817 | Germany |
| MVZ Contilia GmbH | Recruiting | Essen | 45219 | Germany |
| Praxis am Markt Dr. Becker | Recruiting | Essen | 45355 | Germany |
| MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien | Recruiting | Fulda | 36037 | Germany |
| Diabetes-Zentrum-Wilhelmsburg GbR | Recruiting | Hamburg | 21109 | Germany |
| Mesut Durmaz, Hof | Recruiting | Hof | 95030 | Germany |
| Praxisgemeinschaft Jerichow | Recruiting | Jerichow | 39319 | Germany |
| Familienmedizinisches Zentrum Radowsky | Recruiting | Leipzig | 04179 | Germany |
| Praxis Am Oberen Tor - Dr. Simon-Wagner | Recruiting | Lichtenfels | 96215 | Germany |
| Diabeteszentrum Ludwigsburg | Recruiting | Ludwigsburg | 71634 | Germany |
| Institut für Diabetesforschung Osnabrück | Recruiting | Osnabrück | 49080 | Germany |
| ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim | Not yet recruiting | Pohlheim | 35415 | Germany |
| Hegau-Bodensee-Klinikum Singen | Completed | Singen | 78224 | Germany |
| Dr. Schmidt-Reinwald Astrid, Trier | Recruiting | Trier | 54292 | Germany |
| A.O.U. Consorziale Policlinico di Bari | Not yet recruiting | Bari | BA | 70124 | Italy |
| Azienda Ospedaliero Universitaria Renato Dulbecco - Mater Domini | Recruiting | Catanzaro | Calabria | 881100 | Italy |
| AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo | Not yet recruiting | Naples | Campania | 80138 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche | Recruiting | Rome | Lazio | 00168 | Italy |
| DAI Scienze Mediche - UOSD Diabetologia | Recruiting | Messina | Sicily | 98124 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte | Recruiting | Palermo | Sicily | 90127 | Italy |
| AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia | Recruiting | Fermo | The Marches | 63900 | Italy |
| Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo | Recruiting | Florence | Tuscany | 50134 | Italy |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia | Recruiting | Perugia | Umbria | 06129 | Italy |
| Università degli studi G. D'Annunzio Chieti Pescara - CAST | Recruiting | Chieti Scalo | 66100 | Italy |
| Azienda Ospedaliera Luigi Sacco | Not yet recruiting | Milan | 20157 | Italy |
| AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna | Not yet recruiting | Ravenna | 48121 | Italy |
| Azienda Ospealiero Universitaria Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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