What PIONEER 5 measured first
| Measure | Oral Semaglutide 14 mgn=163 | Placebon=161 |
|---|---|---|
| In-trial | -1.1(1.0) | -0.2(0.9) |
| On-treatment without rescue medication | -1.2(0.9) | -0.1(0.9) |
Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment
As posted on ClinicalTrials.gov (NCT02827708), updated at source Feb 17, 2020. 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=163 | Placebon=161 |
|---|---|---|
| In-trial | -1.1(1.0) | -0.2(0.9) |
| On-treatment without rescue medication | -1.2(0.9) | -0.1(0.9) |
Percent of participants affected, Week 0 to week 31 (26 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 | Placebo |
|---|---|---|
| Any serious event | 10.4% | 10.6% |
| Nausea | 19% | 7.5% |
| Constipation | 11.7% | 3.7% |
| Vomiting | 11.7% | 1.2% |
| Diarrhoea | 10.4% | 3.7% |
| Dyspepsia | 9.8% | 1.2% |
| Decreased appetite | 6.7% | 0% |
| Headache | 6.1% | 5% |
| Back pain | 0.6% | 5.6% |
| Measure | Oral Semaglutide 14 mgn=163 | Placebon=161 |
|---|---|---|
| In-trial | -3.5(3.8) | -0.9(2.9) |
| On-treatment without rescue medication | -3.9(3.6) | -0.9(2.9) |
| Oral Semaglutide 14 mgn=151 | Placebon=151 |
|---|---|
| -1.58(2.96) | -0.34(3.03) |
| Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|
| -3.75(4.10) | -0.92(3.13) |
| Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|
| -1.2(1.3) | -0.3(1.0) |
| Oral Semaglutide 14 mgn=152 | Placebon=154 |
|---|---|
| -2.8(4.9) | -0.7(3.8) |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 89 | 35 |
| No | 65 | 120 |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 60 | 12 |
| No | 94 | 143 |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 55 | 15 |
| No | 99 | 140 |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 13 | 0 |
| No | 141 | 155 |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 78 | 27 |
| No | 76 | 128 |
| Measure | Oral Semaglutide 14 mgn=154 | Placebon=155 |
|---|---|---|
| Yes | 60 | 12 |
| No | 94 | 143 |
| Oral Semaglutide 14 mgn=148 | Placebon=153 |
|---|---|
| 0.97(20.1) | 1.00(23.0) |
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.
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 for at least 90 days prior to day of screening * HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive) * Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula * Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens: * 1-2 of the following oral anti-diabetic drugs: * Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record), * Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) * Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or * Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) 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 and randomisation * 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 alanine aminotransferase above 2.5 x upper normal limit * Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g) * Use of systemic immunosuppressive treatment within 90 days prior to screening * Treatment with any medication for the indication of diabetes or...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.