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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1296-9708 | Other Identifier | World Health Organization (WHO) | |
| 2023-509412-28 | Other Identifier | European Medical Agency (EMA) |
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The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo subcutaneous | Placebo Comparator | Placebo for subcutaneous treatment |
|
| NNC0487-0111 subcutaneous dose 1 | Experimental | NNC0487-0111 subcutaneous dose 1 treatment |
|
| NNC0487-0111 subcutaneous dose 2 | Experimental | NNC0487-0111 subcutaneous dose 2 treatment |
|
| NNC0487-0111 subcutaneous dose 3 | Experimental | NNC0487-0111 subcutaneous dose 3 treatment |
|
| NNC0487-0111 subcutaneous dose 4 | Experimental | NNC0487-0111 subcutaneous dose 4 treatment |
|
| NNC0487-0111 subcutaneous dose 5 | Experimental | NNC0487-0111 subcutaneous dose 5 treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 subcutanous | Drug | NNC0487-0111 administered subcutanously (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | percent point | From baseline (week 0) to end of treatment (week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | percent | From baseline (week 0) to end of treatment (week 36) |
| Change in body weight | kg | From baseline (week 0) to end of treatment (week 36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cal Clinical Research | Santa Ana | California | 92701 | United States | ||
| Chase Medical Research LLC |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
|
| NNC0487-0111 subcutaneous dose 6 | Experimental | NNC0487-0111 subcutaneous dose 6 treatment |
|
| Placebo oral | Placebo Comparator | Placebo for oral treatment |
|
| NNC0487-0111 oral dose 1 | Experimental | NNC0487-0111 oral dose 1 treatment |
|
| NNC0487-0111 oral dose 2 | Experimental | NNC0487-0111 oral dose 2 treatment |
|
| NNC0487-0111 oral dose 3 | Experimental | NNC0487-0111 oral dose 3 treatment |
|
| Placebo (NNC0487-0111 subcutanous) | Drug | NNC0487-0111 placebo administered subcutanously (under the skin) |
|
| NNC0487-0111 oral | Drug | NNC0487-0111 administered orally (in the mouth) |
|
| Placebo (NNC0487-0111 oral) | Drug | NNC0487-0111 placebo administered orally (in the mouth) |
|
| Change in fasting plasma glucose (FPG) | mmol/L | From baseline (week 0) to end of treatment (week 36) |
| CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) | percent points | From baseline (week 0) to end of treatment (week 36) |
| Change in body mass index (BMI) | kg/m^2 | From baseline (week 0) to end of treatment (week 36) |
| Change in waist circumference | cm | From baseline (week 0) to end of treatment (week 36) |
| Change in systolic blood pressure (SBP) | mmHg | From baseline (week 0) to end of treatment (week 36) |
| Change in average 24-hour systolic blood pressure (SBP) | mmHg | From baseline (week 0) to end of treatment (week 36) |
| Change in high sensitivity C-Reactive Protein (hsCRP) | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in total cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in high-density lipoprotein (HDL) cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in low-density lipoprotein (LDL) cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in triglycerides | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Number of adverse events | Count of events | From baseline (week 0) to end of study (week 40) |
| Change in Urinary Albumin/Creatinine Ratio (UACR) | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g) | Count of participant | At end of treatment (week 36) |
| Change in eGFR creatinine- and cystatin C based CKD-EPI | mL/min/1.73 m^2 | From baseline (week 0) to end of treatment (week 36) |
| Waterbury |
| Connecticut |
| 06708 |
| United States |
| Fleming Island Ctr for Clin Res | Fleming Island | Florida | 32003 | United States |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Advanced Internal Medicine, PLLC | Paducah | Kentucky | 42001 | United States |
| Medstar Research Institute_Hyattsville | Hyattsville | Maryland | 20782 | United States |
| MD Medical Research | Oxon Hill | Maryland | 20745 | United States |
| Arcturus HC PLC Troy Med Res | Troy | Michigan | 48098 | United States |
| Arcturus Healthcare, PLC | Troy | Michigan | 48098 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| AMC Community Endocrinology | Albany | New York | 12203 | United States |
| Lucas Research Inc. | Morehead City | North Carolina | 28557 | United States |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | United States |
| Plains Clinical Research Center, LLC_Fargo | Fargo | North Dakota | 58104 | United States |
| Preferred Primary Care Physicians_Pittsburgh | Pittsburgh | Pennsylvania | 15236 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| MidState Endocrine Associates | Nashville | Tennessee | 37203 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| Victorium Clinical Research | Houston | Texas | 77024 | United States |
| Synergy Groups Medical | Houston | Texas | 77061 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Radiance Clinical Research | Lampasas | Texas | 76550 | United States |
| Tekton Research | McKinney | Texas | 75069 | United States |
| Hillcrest Family Health Center | Waco | Texas | 76708 | United States |
| Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd. | Kyustendil | 2500 | Bulgaria |
| IPSOMC Dr. Miglena Rizova Ltd. | Kyustendil | 2500 | Bulgaria |
| UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases | Plovdiv | 4001 | Bulgaria |
| UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic | Plovdiv | 4001 | Bulgaria |
| DCC Sveti Georgi EOOD | Plovdiv | 4002 | Bulgaria |
| Diagnostic-Consultative Centre "Sveti Georgi" Eood | Plovdiv | 4002 | Bulgaria |
| Medical centre Regina Life Clinic EOOD | Sofia | 1000 | Bulgaria |
| UMHAT "Aleksandrovska" | Sofia | 1431 | Bulgaria |
| USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology | Sofia | 1431 | Bulgaria |
| USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology | Sofia | 1431 | Bulgaria |
| AIPSMC Dr. Artin Magardichyan EOOD | Varna | 9020 | Bulgaria |
| Poliklinika Solmed | Zagreb | City of Zagreb | 10000 | Croatia |
| Clinical Hospital Centre Rijeka_Endocrinology | Rijeka | Primorje-Gorski Kotar County | 51 000 | Croatia |
| KBC Rijeka, Endokrinologija | Rijeka | Primorje-Gorski Kotar County | 51 000 | Croatia |
| Opca bolnica Karlovac | Karlovac | 47000 | Croatia |
| Specijalna bolnica Krapinske Toplice - Endokrinologija | Krapinske Toplice | 49217 | Croatia |
| Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology | Krapinske Toplice | 49217 | Croatia |
| Klinicki bolnicki centar Osijek_Endocrinology | Osijek | 31 000 | Croatia |
| Klinicki bolnicki centar Osijek | Osijek | 31 000 | Croatia |
| Opca bolnica Varazdin_Endocrinology | Varaždin | 42 000 | Croatia |
| Opca bolnica Varazdin | Varaždin | 42 000 | Croatia |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH | Elsterwerda | 04910 | Germany |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Wendisch/Dahl Hamburg (DZHW) | Hamburg | 22607 | Germany |
| Wendisch/Dahl Hamburg | Hamburg | 22607 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster | 48145 | Germany |
| RED-Institut für medizinische Forschung und Fortbildung GmbH | Oldenburg in Holstein | 23758 | Germany |
| Iatriko Psychicou Private Clinic | Athens | 115 25 | Greece |
| U.G.H of Athens "Attikon" | Athens | 12462 | Greece |
| "Laiko" General Hospital of Athens | Goudi/Athens | 11527 | Greece |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes | Thessaloniki | 54645 | Greece |
| 424 Military General Training Hospital - 2nd Department of Internal Medicine | Thessaloniki | 564 29 | Greece |
| 424 Military General Training Hospital | Thessaloniki | 564 29 | Greece |
| "Thermi" Private Hosital | Thessaloniki | 57001 | Greece |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes | Thessaloniki | GR-54643 | Greece |
| "Thermi" Private Hosital | Thessaloniki | GR-57001 | Greece |
| Debreceni Egyetem | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Bajcsy-Zsilinszky Kórház | Budapest | 1106 | Hungary |
| MH Egészségügyi Központ | Budapest | 1134 | Hungary |
| Debreceni Egyetem | Debrecen | 4031 | Hungary |
| Debreceni Egyetem | Debrecen | H-4031 | Hungary |
| Debreceni Egyetem | Debrecen | H-4032 | Hungary |
| Békés Megyei Központi Kórház | Gyula | 5700 | Hungary |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | 7400 | Hungary |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | H-7400 | Hungary |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| Heiwadai Hospital | Miyazaki | Miyazaki | 880-0034 | Japan |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi | 468-0009 | Japan |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Tokuyama clinic | Chiba | 261-0004 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Naka Kinen Clinic | Ibaraki | 311-0113 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Tokyo-Eki Center-building Clinic | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Fukuwa Clinic | Tokyo | 104-0031 | Japan |
| Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| Formed 2 Sp. z o.o. | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j. | Legnica | Lower Silesian Voivodeship | 59-220 | Poland |
| Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j. | Legnica | Lower Silesian Voivodeship | 59-220 | Poland |
| EKAMED sp. z o.o. | Lublin | Lublin Voivodeship | 20-718 | Poland |
| ETG Siedlce | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| Specderm Poznanska Sp. j. | Bialystok | Podlaskie Voivodeship | 15-375 | Poland |
| NZOZ Vita-Diabetica Malgorzata Buraczyk | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Specderm Poznańska Spółka Jawna | Bialystok | 15-375 | Poland |
| EKAMED sp. z o.o. | Lublin | 20-718 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. | Ruda Śląska | 41-709 | Poland |
| PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Warsaw | 02-507 | Poland |
| Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz | Łódź Voivodeship | 90-302 | Poland |
| SC Grand Med SRL | Oradea | Bihor County | 410025 | Romania |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila | Bucharest | Bucurestii | 020475 | Romania |
| Spitalul Clinic Judetean Urgenta Cluj-Napoca | Cluj-Napoca | Cluj | 400006 | Romania |
| Sc Mediab Srl | Târgu Mureş | Mureș County | 540142 | Romania |
| Novus Medical Clinica SRL | Ploieşti | Prahova | 100018 | Romania |
| Mariodiab Clinic SRL | Brasov | 500101 | Romania |
| Cabinet Medical Dr Geru SRL | Timișoara | 300288 | Romania |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara | Timișoara | 300723 | Romania |
| Peter Farkas MD, s.r.o. | Šahy | Slovak Republic | 93601 | Slovakia |
| DENTAVIA s.r.o. | Poprad | 05801 | Slovakia |
| DIABETOL, s.r.o. | Prešov | 080 01 | Slovakia |
| OLIVER - MED s.r.o. | Rimavská Sobota | 979 01 | Slovakia |
| MEDIVASA, s.r.o., Diabetologicka ambulancia | Žilina | 010 01 | Slovakia |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología | Seville | 41003 | Spain |
| Hospital Infanta Luisa | Seville | 41010 | Spain |
| Hospital Nisa Sevilla Aljarafe | Seville | 41950 | Spain |
| Hospital Vithas Sevilla | Seville | 41950 | Spain |
| 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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