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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1291-4976 | Other Identifier | World Health Organization (WHO) |
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Due to internal reprioritization, trial was cancelled.
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This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 25 mg | Experimental | Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period. |
|
| Semaglutide 50 mg | Experimental | Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period. |
|
| Empagliflozin 25 mg | Experimental | Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period. |
|
| Metformin 2000 mg | Experimental | Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Administered as oral tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured in Percentage (%)-points. | From randomisation (week 0) to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Measured in kilograms (kg). | From randomisation (week 0) to week 52 |
| Change in fasting plasma glucose (FPG) | Measured in millimoles per liter (mmol/L). |
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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 |
|---|---|---|---|---|---|---|
| Hillcrest Family Health Center | Waco | Texas | 76708 | United States | ||
| Instituto de Ciências Farmacêuticas |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Empagliflozin |
| Drug |
Administered as oral tablets. |
|
| Metformin | Drug | Administered as oral tablets. |
|
| From randomisation (week 0) to week 52 |
| Change in 7 point self measured plasma glucose (SMPG) mean profile | Measured in mmol/L. | From randomisation (week 0) to week 52 |
| Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments | Measured in mmol/L. | From randomisation (week 0) to week 52 |
| Relative change in body weight | Measured in Percentage (%). | From randomisation (week 0) to week 52 |
| Change in waist circumference | Measured in centimeters (cm). | From randomisation (week 0) to week 52 |
| HbA1c less than or equal to (≤) 6.5% (Yes/No) | Measured as count of participants. | At week 52 |
| HbA1c less than (<) 7% (Yes/No) | Measured as count of participants. | At week 52 |
| Body weight reduction greater than equal to ( ≥) 5% (Yes/No) | Measured as count of participants. | At week 52 |
| Body weight reduction ≥10% (Yes/No) | Measured as count of participants. | At week 52 |
| Body weight reduction ≥15% (Yes/No) | Measured as count of participants. | At week 52 |
| HbA1c <7.0% and body weight reduction ≥5% (Yes/No) | Measured as count of participants. | At week 52 |
| Change in systolic blood pressure | Measured in millimeters of mercury (mmHg). | From randomisation (week 0) to week 52 |
| Change in diastolic blood pressure | Measured in mmHg. | From randomisation (week 0) to week 52 |
| Change in High-sensitivity C-reactive protein (hsCRP) | Measured in milligrams per liter (mg/L). | From randomisation (week 0) to week 52 |
| Time to rescue medication | Measured in days. | From randomisation (week 0) to week 104 |
| Change in HbA1c | Measured in %-points. | From randomisation (week 0) to week 104 |
| Change in body weight | Measured in kg. | From randomisation (week 0) to week 104 |
| Change in FPG | Measured in mmol/L. | From randomisation (week 0) to week 104 |
| Change in 7 point SMPG mean profile | Measured in mmol/L. | From randomisation (week 0) to week 104 |
| Change in 7-point SMPG mean post prandial increments | Measured in mmol/L | From randomisation (week 0) to week 104 |
| Relative change in body weight | Measured in Percentage. | From randomisation (week 0) to week 104 |
| Change in waist circumference | Measured in cm. | From randomisation (week 0) to week 104 |
| HbA1c ≤6.5% (Yes/No) | Measured as count of participants. | At week 104 |
| HbA1c <7.0% (Yes/No) | Measured as count of participants. | At week 104 |
| Body weight reduction ≥5% (Yes/No) | Measured as count of participants. | At week 104 |
| Body weight reduction ≥10% (Yes/No) | Measured as count of participants. | At week 104 |
| Body weight reduction ≥15% (Yes/No) | Measured as count of participants. | At week 104 |
| HbA1c <7.0% and body weight reduction ≥5% (Yes/No) | Measured as count of participants. | At week 104 |
| Change in systolic blood pressure | Measured in mmHg. | From randomisation (week 0) to week 104 |
| Change in diastolic blood pressure | Measured in mmHg. | From randomisation (week 0) to week 104 |
| Change in hsCRP | Measured in mg/L. | From randomisation (week 0) to week 104 |
| Treatment emergent adverse events | Measured as count of events. | From randomisation (week 0) to week 52 |
| Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes | Measured as count of episodes. | From randomisation (week 0) to week 52 |
| Treatment emergent adverse events | Measured as count of events. | From randomisation (week 0) to follow-up visit (week 109) |
| Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes | Measured as count of episodes. | From randomisation (week 0) to follow-up visit (week 109) |
| Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain | CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control. | From randomisation (week 0) to week 52 |
| Change in CoEQ score - Craving for Savory domain | CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving. | From randomisation (week 0) to week 52 |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100). | From randomisation (week 0) to week 52 |
| Change in American Heart Association (AHA) Life's Simple 7 summary score | The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health. | From randomisation (week 0) to week 52 |
| Change in CoEQ score - Craving Control domain | CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control. | From randomisation (week 0) to week 104 |
| Change in CoEQ score - Craving for Savory domain | CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving. | From randomisation (week 0) to week 104 |
| Change in IWQOL-Lite-CT score - Physical function domain | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100). | From randomisation (week 0) to week 104 |
| Change in AHA Life's Simple 7 summary score | The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health. | From randomisation (week 0) to week 104 |
| Goiânia |
| Goiás |
| 74935-330 |
| Brazil |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
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| CPCLIN - Centro de Pesquisas Clínicas | São Paulo | São Paulo | 01228-200 | Brazil |
| Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd. | Kyustendil | 2500 | Bulgaria |
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| Specijalna bolnica Krapinske Toplice - Endokrinologija | Krapinske Toplice | 49217 | Croatia |
| Opca bolnica Pula | Pula | 52100 | Croatia |
| Specijalna bolnica Medico | Rijeka | 51000 | Croatia |
| Iatriko Psychicou Private Clinic | Athens | 115 25 | Greece |
| "Laiko" General Hospital of Athens | Athens | GR-11527 | Greece |
| Iatriko Athinon (Athens Medical Canter) | Athens | GR-15125 | Greece |
| Iatriko Athinon 'Palaiou Falirou' | Athens | GR-17562 | Greece |
| University Hospital of Athens ATTIKON | Haidari-Athens | GR-12462 | Greece |
| University General Hospital of Ioannina,Internal Medicine | Ioannina | 45500 | Greece |
| General Hospital of Thessaloniki 'G. Gennimatas | Thessaloniki | GR-54635 | Greece |
| EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes | Thessaloniki | GR-54643 | Greece |
| "Thermi" Private Hosital | Thessaloniki | GR-57001 | Greece |
| General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki | GR-57010 | Greece |
| ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft. | Budapest | 1089 | Hungary |
| Belinus Bt. | Debrecen | 4025 | Hungary |
| Osmania General Hospital | Hyderabad | A.P. | 500 063 | India |
| Endolife Specialty Hospitals | Guntur | Andhra Pradesh | 522001 | India |
| Yalamanchi Hospitals and Research centres pvt ltd | Vijaywada | Andhra Pradesh | 520002 | India |
| Navneeth Memorial Hospital | Ahmedabad | Gujarat | 380009 | India |
| Govt Medical College | Vadodara | Gujarat | 390001 | India |
| Ramaiah Memorial Hospital | Bangalore | Karnataka | 560054 | India |
| Lifecare Hospital and Research Centre | Bangalore | Karnataka | 560092 | India |
| K R Hospital | Mysuru | Karnataka | 570001 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | India |
| Goa Medical College | Goa | Maharashtra | 403 202 | India |
| Excel Endocrine Centre | Kolhāpur | Maharashtra | 416008 | India |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| BSES MG hospital | Mumbai | Maharashtra | 400058 | India |
| Ashirwad Hospital and Research Centre | Thane | Maharashtra | 421004 | India |
| Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha | Wardha | Maharashtra | 442001 | India |
| Maulana Azad Medical College | Delhi | New Delhi | 110002 | India |
| Dayanand Medical College & Hospital_Ludhiana | Ludhiana | Punjab | 141001 | India |
| Jawahar Lal Nehru Govt. Medical College | Ajmer | Rajasthan | 305001 | India |
| Diabetes, Thyroid and Endocrine Centre | Jaipur | Rajasthan | 302006 | India |
| M.V.Hospital for Diabetes Pvt. Ltd. | Chennai | Tamil Nadu | 600 013 | India |
| Gandhi Hospital & Medical college | Hyderabad | Telangana | 500003 | India |
| Yashoda hospital | Hyderabad | Telangana | 500082 | India |
| Medanta Lucknow Hospital | Lucknow | Uttar Pradesh | 226030 | India |
| BP Poddar Hospital | Kolkata | West Bengal | 700053 | India |
| Swasthya Diabetes Care | Ahmedabad | 390013 | India |
| Aligarh Muslim University | Aligarh | 202002 | India |
| Sparsh Hospital, Bhubaneshwar | Bhubaneswar | 751007 | India |
| All India Institute of Medical Sciences (AIIMS), Nagpur | Maharashtra | 441108 | India |
| JIPMER | Puducherry | 605006 | India |
| Lifepoint Multispecialty Hospital | Pune | 411057 | India |
| Mahatma Gandhi Memorial Hospital, Sherpura | Warangal | 506002 | India |
| Hospital Miri | Sarawak | Miri | 98000 | Malaysia |
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| Hospital Sultan Haji Ahmad Shah | Temerloh,Pahang | 28000 | Malaysia |
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| Medical Care and Research S. A de C.V | Mérida | Yucatán | 97070 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| ETG Siedlce | Siedlce | Masovian Voivodeship | 08-110 | Poland |
| NZOZ Vita-Diabetica Malgorzata Buraczyk | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Centrum Medyczne Intercor Sp. z o.o. | Bydgoszcz | 85-605 | Poland |
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| Centra Medyczne Medyceusz Sp. z o.o. | Lodz | 91-053 | Poland |
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| ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna | Opole | 45-301 | Poland |
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| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila | Bucharest | Bucurestii | 020475 | Romania |
| Sc Mediab Srl | Târgu Mureş | Mureș County | 540142 | Romania |
| Clinica Grivitei 224 S.R.L. | Brăila | 810197 | Romania |
| SC Nutrilife SRL | Bucharest | 013764 | Romania |
| Diabet Med SRL | Bucharest | 050913 | Romania |
| S.C. Dianutrilife Medica S.R.L. | Ploieşti | 100561 | Romania |
| Clinica Korall S.R.L. Satu Mare | Satu Mare | 440055 | Romania |
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| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| 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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Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
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