What PIONEER 2 measured first
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| In-trial | -1.3(1.1) | -0.9(0.9) |
| On-treatment without rescue medication | -1.5(1.1) | -0.9(0.9) |
Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus
As posted on ClinicalTrials.gov (NCT02863328), updated at source Jul 20, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| In-trial | -1.3(1.1) | -0.9(0.9) |
| On-treatment without rescue medication | -1.5(1.1) | -0.9(0.9) |
Percent of participants affected, Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one.... The most common events the registry lists.
| Event | Oral Semaglutide 14 mg | Empagliflozin 25 mg |
|---|---|---|
| Any serious event | 6.6% | 9% |
| Nausea | 19.8% | 2.4% |
| Diarrhoea | 9.3% | 3.2% |
| Vomiting | 7.3% | 1.7% |
| Decreased appetite | 5.1% | 0.5% |
| Influenza | 2% | 5.1% |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| In-trial | -3.9(4.4) | -3.8(3.8) |
| On-treatment without rescue medication | -4.3(4.4) | -3.9(3.8) |
| Oral Semaglutide 14 mgn=384 | Empagliflozin 25 mgn=382 |
|---|---|
| -1.3(1.2) | -0.9(1.0) |
| Oral Semaglutide 14 mgn=386 | Empagliflozin 25 mgn=383 |
|---|---|
| -4.0(5.5) | -3.7(4.3) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | -2.01(2.56) | -2.08(2.17) |
| Week 52 | -2.04(2.50) | -2.14(2.36) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | -2.3(2.1) | -1.9(2.1) |
| Week 52 | -2.3(2.3) | -2.1(2.3) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | -0.5(1.8) | -0.4(2.0) |
| Week 52 | -0.6(1.8) | -0.4(1.9) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| week 26 | 1.10(35.7) | 0.89(29.4) |
| week 52 | 1.09(37.2) | 0.92(31.6) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | 1.06(50.5) | 0.77(54.1) |
| Week 52 | 1.03(52.8) | 0.77(53.7) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | 0.72(74.6) | 0.66(61.9) |
| Week 52 | 0.74(80.5) | 0.69(57.8) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | 0.91(28.0) | 1.01(27.5) |
| Week 52 | 0.89(27.8) | 0.95(27.6) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | 0.83(63.8) | 0.61(58.7) |
| Week 52 | 0.81(64.9) | 0.60(60.4) |
| Measure | Oral Semaglutide 14 mgn=411 | Empagliflozin 25 mgn=410 |
|---|---|---|
| Week 26 | 1.67(69.5) | 1.16(65.0) |
| Week 52 | 1.66(72.9) | 1.17(69.9) |
This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, age above or equal to 18 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening * HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive) * Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply * Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma * History of pancreatitis (acute or chronic) * History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * Subjects presently classified as being in New York Heart Association Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit * Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days * Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation * History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ) * History of diabetic ketoacidosis
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.