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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1270-0763 | Other Identifier | World Health Organization (WHO) | |
| 2021-005396-39 | EudraCT Number |
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Sponsor decision
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This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral semaglutide | Experimental | Participants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks. |
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| Empagliflozin | Active Comparator | Participants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive 1 tablet of oral semaglutide once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No) | Measured as count of participants. | At week 104 |
| Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No) | Measured as count of participants. | At week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Measured as percentage (%)-point. | From randomisation (week 0) to week 104 |
| 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 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C570240 | empagliflozin |
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| Empagliflozin |
| Drug |
Participants will receive 1 tablet of empagliflozin once daily. |
|
| From randomisation (week 0) to week 104 |
| Change in self-measured plasma glucose (SPMG) 7-point mean profile | Measured in millimoles per liter(mmol/l). | From randomisation (week 0) to week 104 |
| Change in self-measured plasma glucose (SPMG) mean post prandial increments | Measured in millimoles per liter(mmol/l). | From randomisation (week 0) to week 104 |
| Time to additional anti-diabetic medication | Measured in days. | From randomisation (week 0) to week 104 |
| Change in body weight | Measured in kilograms (kg). | From randomisation (week 0) to week 104 |
| Relative change in body weight | Measured as percentage (%). | From randomisation (week 0) to week 104 |
| Change in waist circumference | Measured in centimeters (cm). | From randomisation (week 0) to week 104 |
| Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No) | Measured as count of participants. | From randomisation (week 0) to week 104 |
| Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No) | Measured as count of participants. | From randomisation (week 0) to week 104 |
| Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%) | Measured as count of participants. | From randomisation (week 0) to week 104 |
| Change in systolic blood pressure | Measured in millimiters of mercury (mmHg). | From randomisation (week 0) to week 104 |
| Change in total cholesterol | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Change in high density lipoprotein (HDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Change in low density lipoprotein (LDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Change in very low density lipoprotein (VLDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Change in Triglycerides | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Change in free fatty acids | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |
| Number of treatment emergent adverse events | Measured as count of events. | From randomisation (week 0) to week 109 |
| Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain | Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum). | From randomisation (week 0) to week 104 |
| Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina | Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum). | From randomisation (week 0) to week 104 |
| D004700 | Endocrine System Diseases |