Phase 3 · Semaglutide

PIONEER 7 trial results

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus

Participants
504
Status
completed
Completed
2019-03-27
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02849080), 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.

Primary outcome

What PIONEER 7 measured first

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)Participants · Week 52 · count of participants
MeasureOral Semaglutide Flex- Main Phasen=253Sitagliptin 100 mg- Main Phasen=251
In-trial: Yes13460
In-trial: No96178
On-treatment without rescue medication: Yes12352
On-treatment without rescue medication: No73132
Side effects by arm

Side effects in PIONEER 7

Percent of participants affected, Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.. The most common events the registry lists.

EventOral Semaglutide Flex- Main PhaseSitagliptin 100 mg- Main PhaseOral Semaglutide Flex- SustainabilityOral Semaglutide Flex- SwitchSitagliptin 100 mg- Switch
Any serious event9.5%9.6%14.2%9%7.2%
Nausea20.9%2.4%22.9%17%3.1%
Nasopharyngitis10.3%5.2%13.4%7%10.3%
Diarrhoea8.7%3.2%11.5%10%3.1%
Headache9.9%6%11.5%4%3.1%
Abdominal pain upper6.3%1.2%7.9%6%1%
Dyspepsia5.1%0.8%7.1%4%2.1%
Upper respiratory tract infection3.6%6%7.1%1%4.1%
Vomiting5.5%0.8%7.1%7%2.1%
Arthralgia3.2%3.2%6.7%3%4.1%
Back pain3.6%4.4%6.7%3%5.2%
Influenza4%2.4%5.9%6%4.1%
Gastroenteritis3.6%0.4%5.1%3%0%
Constipation2.8%2.8%4.3%5%1%
Secondary outcomes

What else it measured

Change in Body WeightKilogram (Kg) · Week 0, week 52 · mean
MeasureOral Semaglutide Flex- Main Phasen=253Sitagliptin 100 mg- Main Phasen=251
In-trial-2.7(3.9)-0.7(3.5)
On-treatment without rescue medication-2.9(4.0)-0.9(3.6)
Change in HbA1cPercentage of HbA1c · Week 0, week 52 · mean
Oral Semaglutide Flex- Main Phasen=230Sitagliptin 100 mg- Main Phasen=238
-1.3(0.9)-0.8(1.0)
Change in FPGMillimoles per liter (mmol/L) · Week 0, week 52 · mean
Oral Semaglutide Flex- Main Phasen=229Sitagliptin 100 mg- Main Phasen=232
-2.41(2.35)-1.39(3.13)
Change in Body Weight (%)Percentage change · Week 0, week 52 · mean
Oral Semaglutide Flex- Main Phasen=233Sitagliptin 100 mg- Main Phasen=239
-2.99(4.42)-0.76(3.91)
Change in BMIKilograms per square meter (kg/m^2) · Week 0, Week 52 · mean
Oral Semaglutide Flex- Main Phasen=233Sitagliptin 100 mg- Main Phasen=239
-1.0(1.5)-0.3(1.3)
Change in Waist CircumferenceCentimeters (cm) · Week 0, week 52 · mean
Oral Semaglutide Flex- Main Phasen=231Sitagliptin 100 mg- Main Phasen=237
-2.6(5.3)-0.7(5.1)
Change in Total Cholesterol (Ratio to Baseline)Ratio of total cholesterol · Week 0, Week 52 · geometric mean
Oral Semaglutide Flex- Main Phasen=226Sitagliptin 100 mg- Main Phasen=234
0.96(19.3)1.01(16.2)
Change in LDL Cholesterol (Ratio to Baseline)Ratio of LDL cholesterol · Week 0, week 52 · geometric mean
Oral Semaglutide Flex- Main Phasen=226Sitagliptin 100 mg- Main Phasen=233
0.97(31.8)1.03(27.2)
Change in HDL Cholesterol (Ratio to Baseline)Ratio of HDL cholesterol · Week 0, week 52 · geometric mean
Oral Semaglutide Flex- Main Phasen=226Sitagliptin 100 mg- Main Phasen=233
1.00(14.0)1.02(16.5)
Change in Triglycerides (Ratio to Baseline)Ratio of triglycerides · Week 0, week 52 · geometric mean
Oral Semaglutide Flex- Main Phasen=226Sitagliptin 100 mg- Main Phasen=233
0.89(38.2)0.91(43.1)
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)Score on a scale · Week 0, week 52 · mean
MeasureOral Semaglutide Flex- Main Phasen=253Sitagliptin 100 mg- Main Phasen=251
Physical functioning1.54(7.92)-0.03(7.16)
Role physical0.40(7.82)0.13(8.38)
Bodily pain1.09(9.01)1.20(8.72)
General health1.83(7.65)1.62(6.71)
Vitality1.07(8.16)0.51(7.28)
Social functioning0.38(9.00)0.41(7.86)
Role emotional-0.91(11.71)-0.54(10.58)
Mental health1.21(8.54)0.86(7.97)
PCS1.51(6.39)0.74(5.81)
MCS0.01(8.75)0.26(7.67)
Change in DTSQScore on a scale · Week 0, Week 52 · mean
MeasureOral Semaglutide Flex- Main Phasen=253Sitagliptin 100 mg- Main Phasen=251
1) Satisfaction with treatment1.09(1.61)0.92(1.65)
2) Feeling of unacceptably high blood sugars-1.58(2.13)-1.14(2.13)
3) Feeling of unacceptably low blood sugars-0.15(1.70)-0.24(1.99)
4) Convenience of treatment0.82(1.54)0.59(1.48)
5) Flexibility of current treatment0.80(1.58)0.68(1.51)
6) Satisfaction with understanding of diabetes0.77(1.51)0.77(1.71)
7) Recommending treatment to others0.88(1.54)0.79(1.46)
8) Satisfaction to continue with present treatment1.03(1.66)0.95(1.88)
Total treatment satisfaction score5.39(6.84)4.70(7.23)
The trial

How PIONEER 7 was run

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

  • Semaglutide flexible dosing (3, 7 or 14 mg)
  • Sitagliptin 100 mg
Who could join the trial

Inclusion Criteria: Main phase (the inclusion criteria for the main phase are not reassessed for the extension phase): * 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 Korea only: Male or female, age above or equal to 19 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) 7.5-9.5% (58-80 mmol/mol) (both inclusive) * Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator * Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening: * Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record) * Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) * Sodium glucose co-transporter 2 inhibitors * Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Extension phase: * Informed consent for the extension phase obtained before any trial-related activities for the extension phase. * On randomised treatment with or without rescue medication at week 52. Exclusion Criteria: Main phase (the exclusion criteria for the main phase are not reassessed for the extension phase): * 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 * Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m\^2 as per Chronic Kidney...

Published papers

Papers from PIONEER 7

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

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