A Phase 3 interventional study of Semaglutide and Empagliflozin in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Withdrawn at 101 sites in 13 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.
Drug: Semaglutide
Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.
Drug: Semaglutide
Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.
Drug: Empagliflozin
Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.
Drug: Metformin
Administered as oral tablets.
Administered as oral tablets.
Administered as oral tablets.
Change in glycated haemoglobin (HbA1c)
Measured in Percentage (%)-points.
Time frame: From randomisation (week 0) to week 52
Change in body weight
Measured in kilograms (kg).
Time frame: From randomisation (week 0) to week 52
Change in fasting plasma glucose (FPG)
Measured in millimoles per liter (mmol/L).
Time frame: From randomisation (week 0) to week 52
Change in 7 point self measured plasma glucose (SMPG) mean profile
Measured in mmol/L.
Time frame: From randomisation (week 0) to week 52
Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments
Measured in mmol/L.
Time frame: From randomisation (week 0) to week 52
Relative change in body weight
Measured in Percentage (%).
Time frame: From randomisation (week 0) to week 52
Change in waist circumference
Measured in centimeters (cm).
Time frame: From randomisation (week 0) to week 52
HbA1c less than or equal to (≤) 6.5% (Yes/No)
Measured as count of participants.
Time frame: At week 52
HbA1c less than (<) 7% (Yes/No)
Measured as count of participants.
Time frame: At week 52
Body weight reduction greater than equal to ( ≥) 5% (Yes/No)
Measured as count of participants.
Time frame: At week 52
Body weight reduction ≥10% (Yes/No)
Measured as count of participants.
Time frame: At week 52
Body weight reduction ≥15% (Yes/No)
Measured as count of participants.
Time frame: At week 52
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Time frame: At week 52
Change in systolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: From randomisation (week 0) to week 52
Change in diastolic blood pressure
Measured in mmHg.
Time frame: From randomisation (week 0) to week 52
Change in High-sensitivity C-reactive protein (hsCRP)
Measured in milligrams per liter (mg/L).
Time frame: From randomisation (week 0) to week 52
Time to rescue medication
Measured in days.
Time frame: From randomisation (week 0) to week 104
Change in HbA1c
Measured in %-points.
Time frame: From randomisation (week 0) to week 104
Change in body weight
Measured in kg.
Time frame: From randomisation (week 0) to week 104
Change in FPG
Measured in mmol/L.
Time frame: From randomisation (week 0) to week 104
Change in 7 point SMPG mean profile
Measured in mmol/L.
Time frame: From randomisation (week 0) to week 104
Change in 7-point SMPG mean post prandial increments
Measured in mmol/L
Time frame: From randomisation (week 0) to week 104
Relative change in body weight
Measured in Percentage.
Time frame: From randomisation (week 0) to week 104
Change in waist circumference
Measured in cm.
Time frame: From randomisation (week 0) to week 104
HbA1c ≤6.5% (Yes/No)
Measured as count of participants.
Time frame: At week 104
HbA1c <7.0% (Yes/No)
Measured as count of participants.
Time frame: At week 104
Body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Time frame: At week 104
Body weight reduction ≥10% (Yes/No)
Measured as count of participants.
Time frame: At week 104
Body weight reduction ≥15% (Yes/No)
Measured as count of participants.
Time frame: At week 104
HbA1c <7.0% and body weight reduction ≥5% (Yes/No)
Measured as count of participants.
Time frame: At week 104
Change in systolic blood pressure
Measured in mmHg.
Time frame: From randomisation (week 0) to week 104
Change in diastolic blood pressure
Measured in mmHg.
Time frame: From randomisation (week 0) to week 104
Change in hsCRP
Measured in mg/L.
Time frame: From randomisation (week 0) to week 104
Treatment emergent adverse events
Measured as count of events.
Time frame: From randomisation (week 0) to week 52
Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes
Measured as count of episodes.
Time frame: From randomisation (week 0) to week 52
Treatment emergent adverse events
Measured as count of events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From randomisation (week 0) to week 104
Showing the first 100 of 101 sites across 13 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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