Phase 3 · Semaglutide

PIONEER 11 trial results

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage of HbA1c), Baseline (Week 0), Week 26. Oral Semaglutide 3 mg: -1.1; Oral Semaglutide 7 mg: -1.5; Oral Semaglutide 14 mg: -1.6; Placebo: -0.2.

Participants
521
Status
completed
Completed
2021-10-27
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT04109547), updated at source Sep 19, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What PIONEER 11 measured first

Change From Baseline in Glycosylated Haemoglobin (HbA1c)Percentage of HbA1c · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=114Oral Semaglutide 7 mgn=117Oral Semaglutide 14 mgn=116Placebon=106
-1.1(0.7)-1.5(0.8)-1.6(1.0)-0.2(0.9)
Side effects by arm

Side effects in PIONEER 11

Percent of participants affected, From week 0 to week 31. The most common events the registry lists.

EventOral Semaglutide 3 mgOral Semaglutide 7 mgOral Semaglutide 14 mgPlacebo
Any serious event4.6%7.7%3.9%1.5%
Decreased appetite1.5%4.6%10.9%0%
Diarrhoea3.1%9.2%9.3%1.5%
Upper respiratory tract infection8.5%9.2%7%4.6%
Lipase increased5.4%8.5%3.1%0%
Abdominal distension0.8%7.7%1.6%0.8%
Nausea4.6%3.1%6.2%1.5%
Constipation0.8%5.4%2.3%0%
Hyperlipidaemia3.1%2.3%0.8%5.3%
Secondary outcomes

What else it measured

Change From Baseline in Body Weight (Kilograms [kg])Kg · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=116Placebon=106
-1.1(3.3)-2.2(3.4)-3.1(3.7)-1.1(2.7)
Change From Baseline in Fasting Plasma Glucose (FPG)milligrams per deciliter (mg/dL) · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=114Oral Semaglutide 7 mgn=118Oral Semaglutide 14 mgn=116Placebon=104
-19.07(32.44)-32.28(27.95)-32.50(24.91)0.00(27.49)
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profilemg/dL · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=110Oral Semaglutide 7 mgn=117Oral Semaglutide 14 mgn=115Placebon=104
-29.4(29.3)-43.0(36.1)-44.5(36.9)-10.3(37.5)
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)mg/dL · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=112Oral Semaglutide 7 mgn=117Oral Semaglutide 14 mgn=115Placebon=104
-14.5(34.2)-20.0(39.9)-27.9(40.6)-6.7(35.6)
Change From Baseline in Body Weight (Percentage [%])Percentage change · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=116Placebon=106
-1(4)-3(4)-4(5)-1(3)
Change From Baseline in Body Mass Index (BMI)kilograms per square meter (kg/m^2) · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=116Placebon=106
-0.4(1.2)-0.8(1.2)-1.1(1.3)-0.4(0.9)
Change From Baseline in Waist Circumferencecentimetres (cm) · Baseline (Week 0), Week 26 · mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=116Placebon=105
-2.1(4.5)-2.2(4.8)-2.8(4.4)-1.4(3.3)
Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)Ratio of total cholesterol · Baseline (Week 0), Week 26 · geometric mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=114Placebon=104
0.99(14.75)0.98(16.62)0.94(19.92)1.00(14.45)
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)Ratio of LDL cholesterol · Baseline (Week 0), Week 26 · geometric mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=114Placebon=102
1.00(29.65)1.00(28.35)0.94(31.12)1.00(25.32)
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)Ratio of HDL cholesterol · Baseline (Week 0), Week 26 · geometric mean
Oral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=114Placebon=102
1.03(15.78)1.02(15.41)1.02(17.72)1.04(14.61)
Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)Ratio of triglycerides · Baseline (Week 0), Week 26 · geometric mean
Oral Semaglutide 3 mgn=114Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=114Placebon=102
0.96(45.32)0.90(45.56)0.87(51.82)0.93(49.08)
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health SurveyUnits on a score · Baseline (Week 0), Week 26 · mean
MeasureOral Semaglutide 3 mgn=115Oral Semaglutide 7 mgn=119Oral Semaglutide 14 mgn=115Placebon=106
Physical functioning0.25(4.83)0.97(5.16)0.34(4.24)0.87(4.98)
Role physical0.34(5.70)0.43(5.83)-0.00(5.02)0.33(7.50)
Bodily pain0.11(8.72)-0.86(8.19)-0.34(6.56)0.49(8.40)
General health2.01(7.14)2.51(7.52)1.32(8.61)1.17(5.91)
Vitality1.23(7.62)-0.23(6.96)0.54(8.02)0.49(6.35)
Social functioning0.22(6.26)0.25(7.22)-0.60(6.18)0.98(7.04)
Role emotional0.46(6.94)0.58(8.34)0.33(7.03)-0.04(9.03)
Mental health0.22(7.59)-0.38(7.96)-0.30(7.78)0.05(6.99)
Physical component score0.66(5.21)0.88(4.98)0.39(4.60)0.94(4.71)
Mental component score0.51(6.86)-0.15(7.65)-0.10(6.44)0.08(6.88)
The trial

How PIONEER 11 was run

The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.

  • Oral semaglutide 3mg: Subjects will remain on 3 mg for the entire treatment period (26 weeks)
  • Oral semaglutide 7mg: Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period
  • Oral semaglutide 14mg: Subjects will receive 3 mg for the first 4 weeks, 7 mg for the next 4 weeks and 14 mg for the remainder of the treatment period
  • Placebo (oral semaglutide): Subjects will receive placebo tablets for the entire treatment period
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. For Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus * HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive). Exclusion Criteria: * \- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method. * Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative. * History or presence 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, hospitalization 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. * Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI). * Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN). * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Published papers

Papers from PIONEER 11

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.