Phase 3 · Semaglutide

PIONEER 5 trial results

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Participants
324
Status
completed
Completed
2018-05-15
Sponsor
Novo Nordisk A/S

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.

Primary outcome

What PIONEER 5 measured first

Change in HbA1cPercentage of HbA1c · Week 0, week 26 · mean
MeasureOral Semaglutide 14 mgn=163Placebon=161
In-trial-1.1(1.0)-0.2(0.9)
On-treatment without rescue medication-1.2(0.9)-0.1(0.9)
Side effects by arm

Side effects in PIONEER 5

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.

EventOral Semaglutide 14 mgPlacebo
Any serious event10.4%10.6%
Nausea19%7.5%
Constipation11.7%3.7%
Vomiting11.7%1.2%
Diarrhoea10.4%3.7%
Dyspepsia9.8%1.2%
Decreased appetite6.7%0%
Headache6.1%5%
Back pain0.6%5.6%
Secondary outcomes

What else it measured

Change in Body Weight (kg)kg · Week 0, week 26 · mean
MeasureOral Semaglutide 14 mgn=163Placebon=161
In-trial-3.5(3.8)-0.9(2.9)
On-treatment without rescue medication-3.9(3.6)-0.9(2.9)
Change in FPGmmol/L · Week 0, week 26 · mean
Oral Semaglutide 14 mgn=151Placebon=151
-1.58(2.96)-0.34(3.03)
Change in Body Weight (%)Percentage change · Week 0, week 26 · mean
Oral Semaglutide 14 mgn=154Placebon=155
-3.75(4.10)-0.92(3.13)
Change in BMIkg/m^2 · Week 0, week 26 · mean
Oral Semaglutide 14 mgn=154Placebon=155
-1.2(1.3)-0.3(1.0)
Change in Waist CircumferenceCentimetre (cm) · Week 0, week 26 · mean
Oral Semaglutide 14 mgn=152Placebon=154
-2.8(4.9)-0.7(3.8)
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes8935
No65120
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes6012
No94143
Participants Who Achieve Weight Loss ≥5% (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes5515
No99140
Participants Who Achieve Weight Loss ≥10% (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes130
No141155
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes7827
No76128
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)Participants · Week 26 · count of participants
MeasureOral Semaglutide 14 mgn=154Placebon=155
Yes6012
No94143
Change in Total Cholesterol (Ratio to Baseline)Ratio of total cholesterol · Week 0, week 26 · geometric mean
Oral Semaglutide 14 mgn=148Placebon=153
0.97(20.1)1.00(23.0)
The trial

How PIONEER 5 was run

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.

  • Semaglutide
  • Placebo
Who could join the trial

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...

Published papers

Papers from PIONEER 5

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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