Primary outcome
What PIONEER 10 measured first
| Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|
| 330 | 350 | 324 | 178 |
Phase 3 · Dulaglutide
PIONEER 10 trial results
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
Number of Treatment-emergent Adverse Events (TEAEs) (Events), Weeks 0-57. Oral Semaglutide 3 mg: 330; Oral Semaglutide 7 mg: 350; Oral Semaglutide 14 mg: 324; Dulaglutide 0.75 mg: 178.
- Participants
- 458
- Status
- completed
- Completed
- 2018-07-12
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT03015220), updated at source Mar 2, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in PIONEER 10
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 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg |
|---|---|---|---|---|
| Any serious event | 6.9% | 3% | 5.4% | 1.5% |
| Nasopharyngitis | 26% | 29.5% | 30% | 29.2% |
| Constipation | 9.2% | 12.1% | 15.4% | 9.2% |
| Nausea | 5.3% | 8.3% | 9.2% | 9.2% |
| Decreased appetite | 0% | 9.1% | 4.6% | 4.6% |
| Diabetic retinopathy | 4.6% | 9.1% | 3.8% | 3.1% |
| Diarrhoea | 1.5% | 1.5% | 7.7% | 6.2% |
| Upper respiratory tract inflammation | 3.1% | 3% | 2.3% | 7.7% |
| Abdominal discomfort | 2.3% | 4.5% | 6.9% | 1.5% |
| Influenza | 6.9% | 6.8% | 3.8% | 3.1% |
| Vomiting | 2.3% | 0.8% | 6.9% | 1.5% |
| Back pain | 3.1% | 3.8% | 2.3% | 6.2% |
| Gastrooesophageal reflux disease | 3.8% | 1.5% | 6.2% | 0% |
Secondary outcomes
What else it measured
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -1.1(0.9) | -1.7(0.9) | -2.0(1.0) | -1.6(0.9) |
| Week 52 | -0.8(1.0) | -1.4(1.0) | -1.8(1.0) | -1.4(0.9) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -1.23(1.54) | -2.25(1.93) | -2.72(1.86) | -2.22(1.71) |
| Week 52 | -0.95(1.72) | -1.96(1.72) | -2.18(2.50) | -1.80(1.71) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -1.8(2.2) | -2.7(2.1) | -3.5(2.3) | -2.9(2.4) |
| Week 52 | -1.7(2.1) | -2.5(2.4) | -3.3(2.6) | -2.6(2.6) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -0.9(2.5) | -1.3(2.0) | -1.2(2.4) | -0.7(2.3) |
| Week 52 | -0.6(2.6) | -0.8(2.0) | -0.9(2.6) | -0.7(2.3) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -0.1(2.0) | -1.0(3.0) | -2.2(3.2) | 0.3(2.1) |
| Week 52 | 0.0(2.4) | -0.9(3.4) | -1.7(3.5) | 1.0(2.7) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -0.28(2.79) | -1.49(4.25) | -3.21(4.32) | 0.25(3.33) |
| Week 52 | -0.02(3.28) | -1.34(4.77) | -2.33(4.67) | 1.25(4.06) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | -0.1(0.7) | -0.4(1.1) | -0.8(1.2) | 0.1(0.8) |
| Week 52 | -0.0(0.9) | -0.3(1.3) | -0.6(1.3) | 0.3(1.0) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | 0.0(3.1) | -0.6(3.4) | -1.2(4.3) | 0.3(2.9) |
| Week 52 | -0.1(3.6) | -0.8(3.9) | -1.7(4.2) | 0.7(3.6) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | 0.96(9.4) | 0.91(12.3) | 0.91(12.3) | 0.92(8.8) |
| Week 52 | 0.98(12.7) | 0.95(13.3) | 0.94(12.5) | 0.93(11.4) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | 0.92(15.9) | 0.88(18.4) | 0.87(20.7) | 0.88(14.5) |
| Week 52 | 0.98(17.4) | 0.94(19.0) | 0.92(18.6) | 0.91(16.2) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | 1.02(13.1) | 0.99(12.8) | 1.00(12.5) | 0.99(11.6) |
| Week 52 | 1.03(11.2) | 0.99(14.5) | 1.01(13.1) | 1.00(11.6) |
| Measure | Oral Semaglutide 3 mgn=131 | Oral Semaglutide 7 mgn=132 | Oral Semaglutide 14 mgn=130 | Dulaglutide 0.75 mgn=65 |
|---|---|---|---|---|
| Week 26 | 1.03(37.9) | 0.92(32.3) | 0.96(33.6) | 0.93(33.5) |
| Week 52 | 0.90(33.3) | 0.87(39.4) | 0.86(36.9) | 0.88(31.6) |
The trial
How PIONEER 10 was run
This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.
- Oral semaglutide 3 mg
- Oral semaglutide 7 mg
- Oral semaglutide 14 mg
- Dulaglutide 0.75 mg
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 * Japanese male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening * HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive) * OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling 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 measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives * 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 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 (TIA) within the past 180 days prior to the day of screening and randomisation * 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 alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) * Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) * Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening * For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening * Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days * Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or...
Published papers
Papers from PIONEER 10
- Ishii H, Hansen BB, Langer J, Horio H. Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.
- Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.
- Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
- Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.
- Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 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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