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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1283-8648 | Other Identifier | World Health Organization (WHO) | |
| 2022-502484-38-00 | Other Identifier | European Medicines Agency (EMA) |
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This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IcoSema | Experimental | Participants will receive once weekly IcoSema subcutaneously with or without oral anti diabetic drugs for 40 weeks. |
|
| Insulin glargine | Experimental | Participants will receive once daily insulin glargine subcutaneously with or without oral anti diabetic drugs for 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IcoSema | Drug | IcoSema will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured in percentage (%)-point. | From baseline (week 0) to week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Measured in kilogram (kg). | From baseline (week 0) to week 40 |
| Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) | Measured in % of readings. |
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Inclusion Criteria:
Male or female and age above or equal to 18 years at the time of signing the informed consent.
Diagnosed with T2D greater than or equal to (≥) 180 days before screening.
HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole [mmol/mol]) as assessed by central laboratory on the day of screening.
Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) at effective or maximum tolerated dose.
Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m^2).
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 |
|---|---|---|---|---|---|---|
| Univ of Alabama_Birmingham | Birmingham | Alabama | 35233 | United States | ||
| John Muir Physicians Network |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Insulin glargine |
| Drug |
Insulin glargine will be administered subcutaneously. |
|
| From week 36 to week 40 |
| Time spent less than (<) 3.0 mmol/L (54 mg/dL) | Measured in % of readings. | From week 36 to week 40 |
| Time spent greater than (>) 10.0 mmol/L (180 mg/dL) | Measured in % of readings. | From week 36 to week 40 |
| Weekly basal insulin dose | Measured in units of insulin. | From week 38 to week 40 |
| Change in fasting plasma glucose (FPG) | Measured in mmol/l. | From baseline (week 0) to week 40 |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction | The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication. | From baseline (week 0) to week 40 |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) | Measured in number of episodes. | From baseline (week 0) to week 45 |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) | Measured in number of episodes. | From baseline (week 0) to week 45 |
| Number of severe hypoglycaemic episodes (level 3) | Measured in number of episodes. | From baseline (week 0) to week 45 |
| Concord |
| California |
| 94520 |
| United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| First Valley Med Grp Lancaster | Lancaster | California | 93534 | United States |
| Clinical Trials Research_Sacramento | Lincoln | California | 95821 | United States |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 91355 | United States |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | United States |
| Northeast Research Institute | Fleming Island | Florida | 32003 | United States |
| East Coast Institute For Research | Jacksonville | Florida | 32208 | United States |
| Clinical Research of Cent FL | Winter Haven | Florida | 33880 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | United States |
| East West Medical Research Institute_Honolulu | Honolulu | Hawaii | 96814 | United States |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | United States |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | United States |
| Endo and Metab Consultants | Rockville | Maryland | 20852 | United States |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | United States |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| AMC Community Endocrinology | Albany | New York | 12203 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | United States |
| Advanced Medical Research | Maumee | Ohio | 43537 | United States |
| New Venture Medical Research | Wadsworth | Ohio | 44281-9236 | United States |
| Essential Medical Research LLC | Tulsa | Oklahoma | 74137 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | United States |
| Velocity Clinical Research- Cedar Park | Austin | Texas | 78759 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | United States |
| Fmc Science, Llc | Lampasas | Texas | 76550 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| Flourish Research | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | United States |
| Wade Family Medicine | Bountiful | Utah | 84010 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Peking University People's Hospital-Endocrinology | Beijing | Beijing Municipality | 100044 | China |
| Beijing Friendship Hospital, Capital Medical University-Endocrinology | Beijing | Beijing Municipality | 100050 | China |
| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| Huizhou Central People's Hospital-Endocrinology | Huizhou | Guangdong | 516001 | China |
| Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology | Hengshui | Hebei | 053000 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212001 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shanghai Pudong New Area People's Hospital-Endocrinology | Shanghai | Shanghai Municipality | 201200 | China |
| Evangelismos Hospital | Athens | 10676 | Greece |
| 'G. Gennimatas' General Hospital of Athens | Athens | 115 27 | Greece |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| General Hospital of Kalamata - B Internal Medicine Department | Kalamata | 24100 | Greece |
| Univ Gen Hospital Larisa | Larissa | 41110 | Greece |
| "Thermi" Private Hosital | Thessaloniki | 57001 | Greece |
| Ramaiah Memorial Hospital | Bangalore | Karnataka | 560054 | India |
| Sai A Health Wellness LLP | Bangalore | Karnataka | 560080 | India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| CHL Hospitals | Indore | Madhya Pradesh | 452008 | India |
| Goa Medical College | Goa | Maharashtra | 403 202 | India |
| BYL Nair Hospital and T N Medical College Department of endo | Mumbai | Maharashtra | 400008 | India |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| BSES MG hospital | Mumbai | Maharashtra | 400058 | India |
| Chellaram Diabetes Institute | Pune | Maharashtra | 411021 | India |
| SMS Medical College & Hospital | Jaipur | Rajasthan | 302004 | India |
| Diabetes, Thyroid and Endocrine Centre | Jaipur | Rajasthan | 302006 | India |
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600086 | India |
| Udyaan Health Care | Lucknow | Uttar Pradesh | 226002 | India |
| Post Graduate Institute of Medical Education & Research | Chandigarh | 160012 | India |
| IPGME&R and SSKM Hospital | Kolkata | 700020 | India |
| METTA Clinic (a unit of Healious Global Pvt. Ltd.) | Kolkata | 700039 | India |
| ASL Avezzano Sulmona L'Aquila - Ospedale San Salvatore - UOC Diabetologia | L’Aquila | Abbruzzo | 67100 | Italy |
| Casa Sollievo della Sofferenza reparto endocrinologia | San Giovanni Rotondo | FG | 71013 | Italy |
| A.O.U. Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani | Ancona | 60127 | Italy |
| Casa della Salute di Ceccano - Ambulatori Campus Biomedico | Ceccano (Frosinone) | 03023 | Italy |
| Polo Ospedaliero di Chiavari | Chiavari (genova) | 16043 | Italy |
| Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia | Perugia | 06129 | Italy |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine | Hokkaido | 060-0001 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Juntendo University Hospital_Diabetes, endocrinology and metabolism | Tokyo | 113-8431 | Japan |
| NZOZ Przychodnia Specjalistyczna Medica | Lublin | Lubelski | 20-538 | Poland |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska | Bialystok | Podlaskie Voivodeship | 15-435 | Poland |
| SNZOZ Lege Artis | Bialystok | 15-404 | Poland |
| Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii | Gdansk | 80-214 | Poland |
| Care Clinic Sp. z o. o. | Katowice | 40-568 | Poland |
| Grazyna Pulka Specjalistyczny Osrodek "All-Med" | Krakow | 30-033 | Poland |
| Gabinet Lekarski Malgorzata Saryusz-Wolska | Lodz | 90-132 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | 90-338 | Poland |
| Velocity Nova Sp. z o.o. | Lublin | 20-362 | Poland |
| NBR Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Warsaw | 02-507 | Poland |
| Medical Concierge Centrum Medyczne | Warsaw | 02-798 | Poland |
| Clinhouse Centrum Medyczne | Zabrze | 41-807 | Poland |
| Velocity Nova Sp. z o.o. | Staszów | Świętokrzyskie Voivodeship | 28-200 | Poland |
| Advanced Clinical Research LLC | Bayamón | 00959 | Puerto Rico |
| Dr R Dulabh | Johannesburg | Gauteng | 1812 | South Africa |
| Newtown Clinical Research | Johannesburg | Gauteng | 2001 | South Africa |
| Roodepoort Medicross Clinical Research Centre | Roodepoort | Gauteng | 1724 | South Africa |
| Dr Pillay's Rooms | Durban | KwaZulu-Natal | 4450 | South Africa |
| Clinical Research Institute of South Africa | KwaDukuza | KwaZulu-Natal | 4449 | South Africa |
| Langeberg Clinical Trials | Cape Town | Western Cape | 7572 | South Africa |
| Akdeniz University Tip Fakultesi Hastanesi | Antalya | 07058 | Turkey (Türkiye) |
| Akdeniz Üniversitesi Hastanesi- Endokrinoloji | Antalya | 07058 | Turkey (Türkiye) |
| Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi | Istanbul | 34371 | Turkey (Türkiye) |
| Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji | Istanbul | 34371 | Turkey (Türkiye) |
| İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji | Istanbul | 34390 | Turkey (Türkiye) |
| Başakşehir Çam ve Sakura Şehir Hastanesi | Istanbul | 34480 | Turkey (Türkiye) |
| T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi | Istanbul | 34899 | Turkey (Türkiye) |
| Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye | Tekirdağ | 59030 | Turkey (Türkiye) |
| 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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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