Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes
As posted on ClinicalTrials.gov (NCT03552757), updated at source Nov 9, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Measure | Semaglutide 2.4 mgn=404 | Placebon=403 |
|---|---|---|
| In-trial observation period | -9.9(8.0) | -3.3(5.5) |
| On-treatment observation period | -10.7(7.8) | -3.1(5.2) |
| Measure | Semaglutide 2.4 mgn=404 | Placebon=403 |
|---|---|---|
| In-trial observation period: Yes | 267 | 107 |
| In-trial observation period: No | 121 | 269 |
| On-treatment observation period: Yes | 257 | 94 |
| On-treatment observation period: No | 94 | 246 |
Percent of participants affected, Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.. The most common events the registry lists.
| Event | Semaglutide 1.0 mg | Semaglutide 2.4 mg | Placebo |
|---|---|---|---|
| Any serious event | 7.7% | 9.9% | 9.2% |
| Nausea | 31.8% | 33.5% | 9.2% |
| Diarrhoea | 21.9% | 21.3% | 11.9% |
| Vomiting | 13.4% | 21.3% | 2.7% |
| Constipation | 12.7% | 17.4% | 5.5% |
| Nasopharyngitis | 11.7% | 16.9% | 14.7% |
| Upper respiratory tract infection | 9.2% | 10.4% | 9.5% |
| Decreased appetite | 7.2% | 9.4% | 3.7% |
| Headache | 8.2% | 7.7% | 5% |
| Back pain | 7% | 6.7% | 3.5% |
| Fatigue | 4.7% | 6.9% | 1% |
| Dyspepsia | 6.7% | 6.2% | 1.2% |
| Abdominal distension | 2.2% | 6% | 2.7% |
| Arthralgia | 6% | 5.7% | 5% |
| Flatulence | 5.2% | 4% | 1.7% |
| Gastroenteritis | 5.2% | 2.7% | 3% |
| Semaglutide 2.4 mgn=388 | Semaglutide 1.0 mgn=380 |
|---|---|
| -9.9(8.0) | -7.2(6.6) |
| Measure | Semaglutide 2.4 mgn=388 | Semaglutide 1.0 mgn=380 |
|---|---|---|
| Yes | 267 | 217 |
| No | 121 | 163 |
| Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=387 | Placebon=375 |
|---|---|---|
| -6.9(6.8) | -9.7(8.1) | -4.3(6.5) |
| Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=388 | Placebon=376 |
|---|---|---|
| -7.1(6.7) | -9.9(8.5) | -3.4(6.2) |
| Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=388 | Placebon=376 |
|---|---|---|
| -2.6(2.4) | -3.6(3.1) | -1.2(2.1) |
| Measure | Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=388 | Placebon=376 |
|---|---|---|---|
| Yes | 109 | 177 | 31 |
| No | 271 | 211 | 345 |
| Measure | Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=388 | Placebon=376 |
|---|---|---|---|
| Yes | 52 | 100 | 12 |
| No | 328 | 288 | 364 |
| Measure | Semaglutide 1.0 mgn=380 | Semaglutide 2.4 mgn=388 | Placebon=376 |
|---|---|---|---|
| Yes | 18 | 51 | 6 |
| No | 362 | 337 | 370 |
| Semaglutide 1.0 mgn=376 | Semaglutide 2.4 mgn=381 | Placebon=374 |
|---|---|---|
| -1.5(1.1) | -1.7(1.2) | -0.3(1.3) |
| Semaglutide 1.0 mgn=376 | Semaglutide 2.4 mgn=381 | Placebon=374 |
|---|---|---|
| -16.9(12.3) | -18.7(13.0) | -3.4(14.3) |
| Semaglutide 1.0 mgn=367 | Semaglutide 2.4 mgn=375 | Placebon=370 |
|---|---|---|
| -36.5(45.1) | -37.9(45.9) | -2.3(53.1) |
| Semaglutide 1.0 mgn=352 | Semaglutide 2.4 mgn=360 | Placebon=351 |
|---|---|---|
| 0.94(59.8) | 0.90(65.4) | 0.93(53.6) |
This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years
Inclusion Criteria: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body Mass Index (BMI) greater than or equal to 27 kg/m\^2 ' * History of at least one self-reported unsuccessful dietary effort to lose body weight * Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening Exclusion Criteria: * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 ml/min/1.73 m\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.