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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

Short name PIONEER 11

NCTNCT04109547 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4338Other idU1111-1188-1173Other id2018-002590-22Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
521 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

Algeria, China, Hungary, Serbia, Taiwan, Ukraine

Start
1 Oct 2019
Primary completion
23 Sept 2021
Completion
27 Oct 2021
First posted
30 Sept 2019
Last update posted
19 Sept 2024
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 3

    PIONEER 11

    NCT04109547

    1 Oct 2019 to 27 Oct 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oral semaglutideDrug
  • PlaceboDrug

Arms4

  • Experimental

    Oral semaglutide 3mg

    Subjects will remain on 3 mg for the entire treatment period (26 weeks)

  • Experimental

    Oral semaglutide 7mg

    Subjects will receive 3 mg for for the first 4 weeks, 7 mg for the remainder of the treatment period

  • Experimental

    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 comparator

    Placebo (oral semaglutide)

    Subjects will receive placebo tablets for the entire treatment period

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

Secondary outcomes(20)

  1. Change From Baseline in Body Weight (Kilograms [kg])

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  2. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  3. Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  4. Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  5. Change From Baseline in Body Weight (Percentage [%])

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  6. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  7. Change From Baseline in Waist Circumference

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  8. Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  9. Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  10. Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  11. Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

    Time frame · Baseline (Week 0), Week 26

    Registry description

    Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  12. Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

    Time frame · Baseline (Week 0), Week 26

    Registry description

    SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  13. Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved HbA1c \< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  14. Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved HbA1c \<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  15. Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved HbA1c reduction \>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  16. Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved body weight loss \>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  17. Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved body weight loss \>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  18. Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved body weight loss \>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  19. Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

  20. Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)

    Time frame · Week 26

    Registry description

    Number of participants who achieved HbA1c reduction \>= 1% (10.9 mmol/mol) and body weight loss \>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

GroupValue (Percentage of HbA1c)Spread
Oral Semaglutide 3 mg-1.10.7
Oral Semaglutide 7 mg-1.50.8
Oral Semaglutide 14 mg-1.61.0
Placebo-0.20.9
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Body Weight (Kilograms [kg])

GroupValue (Kg)Spread
Oral Semaglutide 3 mg-1.13.3
Oral Semaglutide 7 mg-2.23.4
Oral Semaglutide 14 mg-3.13.7
Placebo-1.12.7
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Fasting Plasma Glucose (FPG)

GroupValue (milligrams per deciliter (mg/dL))Spread
Oral Semaglutide 3 mg-19.0732.44
Oral Semaglutide 7 mg-32.2827.95
Oral Semaglutide 14 mg-32.5024.91
Placebo0.0027.49
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

GroupValue (mg/dL)Spread
Oral Semaglutide 3 mg-29.429.3
Oral Semaglutide 7 mg-43.036.1
Oral Semaglutide 14 mg-44.536.9
Placebo-10.337.5
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)

GroupValue (mg/dL)Spread
Oral Semaglutide 3 mg-14.534.2
Oral Semaglutide 7 mg-20.039.9
Oral Semaglutide 14 mg-27.940.6
Placebo-6.735.6
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Body Weight (Percentage [%])

GroupValue (Percentage change)Spread
Oral Semaglutide 3 mg-14
Oral Semaglutide 7 mg-34
Oral Semaglutide 14 mg-45
Placebo-13
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Body Mass Index (BMI)

GroupValue (kilograms per square meter (kg/m^2))Spread
Oral Semaglutide 3 mg-0.41.2
Oral Semaglutide 7 mg-0.81.2
Oral Semaglutide 14 mg-1.11.3
Placebo-0.40.9
Secondary outcomeMean· Baseline (Week 0), Week 26

Change From Baseline in Waist Circumference

GroupValue (centimetres (cm))Spread
Oral Semaglutide 3 mg-2.14.5
Oral Semaglutide 7 mg-2.24.8
Oral Semaglutide 14 mg-2.84.4
Placebo-1.43.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oral Semaglutide 3 mgParticipants received oral semaglutide 3 mg tablets once daily from week 0 to week 26.0 / 1306 / 13030 / 130
Oral Semaglutide 7 mgParticipants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26.0 / 13010 / 13047 / 130
Oral Semaglutide 14 mgParticipants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26.0 / 1295 / 12940 / 129
PlaceboParticipants received oral semaglutide matching placebo tablets once daily from week 0 to week 26.0 / 1312 / 13116 / 131

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

12 results

Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial.

Wang et al. 2024Diabetologiacited by 23

PMID 38985162PMC11410837DOI 10.1007/s00125-024-06142-3PUB-38985162

CC BY12 results
Download PDFSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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