What PIONEER 4 measured first
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| In-trial | -1.2(0.9) | -1.1(0.9) | -0.1(0.7) |
| On-treatment without rescue medication | -1.4(0.9) | -1.2(0.9) | -0.1(0.7) |
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
As posted on ClinicalTrials.gov (NCT02863419), 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=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| In-trial | -1.2(0.9) | -1.1(0.9) | -0.1(0.7) |
| On-treatment without rescue medication | -1.4(0.9) | -1.2(0.9) | -0.1(0.7) |
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 | Liraglutide 1.8 mg | Placebo |
|---|---|---|---|
| Any serious event | 10.9% | 7.7% | 10.6% |
| Nausea | 19.3% | 18% | 3.5% |
| Diarrhoea | 15.1% | 10.9% | 7.7% |
| Nasopharyngitis | 14.4% | 13% | 10.6% |
| Headache | 9.5% | 6% | 5.6% |
| Vomiting | 8.4% | 4.6% | 2.1% |
| Constipation | 7.7% | 3.9% | 2.8% |
| Decreased appetite | 5.6% | 7% | 0% |
| Blood glucose increased | 0% | 0.7% | 6.3% |
| Back pain | 3.9% | 6% | 3.5% |
| Abdominal pain | 5.6% | 2.1% | 2.1% |
| Dyspepsia | 5.6% | 4.2% | 0% |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| In-trial | -4.4(4.4) | -3.2(3.7) | -0.6(3.1) |
| On-treatment without rescue medication | -4.7(4.3) | -3.3(3.7) | -0.7(3.1) |
| Oral Semaglutide 14 mgn=275 | Liraglutide 1.8 mgn=269 | Placebon=133 |
|---|---|---|
| -1.2(1.0) | -0.9(1.0) | -0.1(0.9) |
| Oral Semaglutide 14 mgn=275 | Liraglutide 1.8 mgn=269 | Placebon=133 |
|---|---|---|
| -4.4(5.5) | -3.1(4.4) | -1.0(3.8) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | -4.89(4.95) | -3.33(3.78) | -0.60(3.34) |
| Week 52 | -4.94(6.37) | -3.25(4.33) | -0.99(4.12) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | -2.04(2.28) | -1.91(2.05) | -0.33(2.03) |
| Week 52 | -1.91(2.41) | -1.54(2.41) | -0.66(1.99) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | -1.6(1.6) | -1.1(1.3) | -0.2(1.1) |
| Week 52 | -1.6(2.0) | -1.1(1.5) | -0.4(1.4) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | -4.2(5.4) | -3.0(4.5) | -1.2(3.9) |
| Week 52 | -4.4(6.1) | -2.7(5.1) | -1.7(4.7) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | 0.96(20.3) | 0.97(21.6) | 0.99(17.0) |
| Week 52 | 0.98(20.5) | 0.98(19.6) | 1.02(18.3) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | 0.95(29.9) | 0.97(43.6) | 0.99(30.8) |
| Week 52 | 0.99(31.6) | 1.00(38.5) | 1.06(33.1) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | 0.90(43.5) | 0.91(37.1) | 1.02(29.4) |
| Week 52 | 0.87(41.9) | 0.90(37.5) | 0.98(39.8) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | 1.02(13.8) | 1.02(15.2) | 1.02(12.2) |
| Week 52 | 1.03(13.8) | 1.01(14.7) | 1.00(12.7) |
| Measure | Oral Semaglutide 14 mgn=285 | Liraglutide 1.8 mgn=284 | Placebon=142 |
|---|---|---|---|
| Week 26 | 0.89(48.4) | 0.91(38.3) | 1.01(34.7) |
| Week 52 | 0.87(47.0) | 0.89(41.1) | 0.97(43.4) |
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo 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. For Japan only: Male or female, age at least 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening. * HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive) * Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed) 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 (MEN 2) or Medullary Thyroid Carcinoma (MTC) * History of pancreatitis (acute or chronic) * History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * Any of the following: myocardial infarction (MI), 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 (NYHA) Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL) * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) 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.