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A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes (PIONEER 11)

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ClinicalTrials.gov Identifier: NCT04109547
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Oral semaglutide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 7, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Oral semaglutide 3mg
Subjects will remain on 3 mg for the entire treatment period (26 weeks)
Drug: Oral semaglutide
Tablets to be taken once-daily for 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
Drug: Oral semaglutide
Tablets to be taken once-daily for 26 weeks

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
Drug: Oral semaglutide
Tablets to be taken once-daily for 26 weeks

Placebo Comparator: Placebo (oral semaglutide)
Subjects will receive placebo tablets for the entire treatment period
Drug: Placebo
Tablets to be taken once-daily for 26 weeks




Primary Outcome Measures :
  1. Change in (glycosylated haemoglobin) HbA1c [ Time Frame: Week 0, week 26 ]
    percent


Secondary Outcome Measures :
  1. Change in body weight [ Time Frame: Week 0, week 26 ]
    kg

  2. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ]
    mg/dl

  3. Change in fasting 7 point self-measured plasma glucose (SMPG) profile: Mean 7-point profile [ Time Frame: Week 0, week 26 ]
    Mean daytime glucose value

  4. Change in fasting 7 point self-measured plasma glucose (SMPG) profile: Mean postprandial increment (over all meals) [ Time Frame: Week 0, week 26 ]
    Mean glucose value over all meals

  5. Change in body weight [ Time Frame: Week 0, week 26 ]
    percent

  6. Change in body mass index (BMI) [ Time Frame: Week 0, week 26 ]
    kg/m^2

  7. Change in waist circumference [ Time Frame: Week 0, week 26 ]
    cm

  8. Change in fasting lipid profile: total cholesterol [ Time Frame: Week 0, week 26 ]
    mg/dl

  9. Change in fasting lipid profile: low-density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, week 26 ]
    mg/dl

  10. Change in fasting lipid profile: high-density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, week 26 ]
    mg/dl

  11. Change in fasting lipid profile: triglycerides [ Time Frame: Week 0, week 26 ]
    mg/dl

  12. Change in Short Form-36 version 2 (SF-36v2™) (acute version) health survey [ Time Frame: Week 0, week 26 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health. Range of score: 1-100 (1 representing worst results and 100 representing best results)

  13. If a subject achieves HbA1c below 7.0 percent (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  14. If a subject achieves HbA1c equal to or below 6.5 percent (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  15. If a subject achieves HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  16. If a subject achieves body weight loss equal to or above 3 percent (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  17. If a subject achieves body weight loss equal to or above 5 percent (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  18. If a subject achieves body weight loss equal to or above 10 percent (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects

  19. If a subject achieves HbA1c below 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects fulfilling the criteria

  20. If a subject achieves HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) [ Time Frame: After 26 weeks ]
    Proportion of subjects fulfilling the criteria

  21. Time to rescue medication [ Time Frame: Week 0 - week 31 ]
    Days/weeks/months

  22. Number of treatment-emergent adverse events (TEAEs) during exposure to trial product [ Time Frame: Week 0 - week 31 ]
    Count

  23. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during exposure to trial product [ Time Frame: Week 0 - week 31 ]
    Count

  24. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during exposure to trial product (yes/no) [ Time Frame: Week 0 - week 31 ]
    Count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109547


Contacts
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Contact: Novo Nordisk '(+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04109547     History of Changes
Other Study ID Numbers: NN9924-4338
U1111-1188-1173 ( Other Identifier: World Health Organization (WHO) )
2018-002590-22 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases