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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04109547
Collaborator
(none)
533
Enrollment
65
Locations
4
Arms
24.9
Actual Duration (Months)
8.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Drug: Oral semaglutide
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
533 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 :
Oct 1, 2019
Actual Primary Completion Date :
Sep 23, 2021
Actual Study Completion Date :
Oct 27, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Change in (glycosylated haemoglobin) HbA1c [Week 0, week 26]

    percent

Secondary Outcome Measures

  1. Change in body weight [Week 0, week 26]

    kg

  2. Change in fasting plasma glucose (FPG) [Week 0, week 26]

    mg/dl

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

    Mean glucose value over all meals

  5. Change in body weight [Week 0, week 26]

    percent

  6. Change in body mass index (BMI) [Week 0, week 26]

    kg/m^2

  7. Change in waist circumference [Week 0, week 26]

    cm

  8. Change in fasting lipid profile: total cholesterol [Week 0, week 26]

    mg/dl

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

    mg/dl

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

    mg/dl

  11. Change in fasting lipid profile: triglycerides [Week 0, week 26]

    mg/dl

  12. Change in Short Form-36 version 2 (SF-36v2™) (acute version) health survey [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) [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) [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) [After 26 weeks]

    Proportion of subjects

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

    Proportion of subjects

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

    Proportion of subjects

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

    Proportion of subjects fulfilling the criteria

  21. Time to rescue medication [Week 0 - week 31]

    Days/weeks/months

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

    Count

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

    Count

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

    Count

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteAlgiersAlgeria16000
2Novo Nordisk Investigational SiteAlgiersAlgeria16049
3Novo Nordisk Investigational SiteHefeiAnhuiChina230061
4Novo Nordisk Investigational SiteBeijingBeijingChina101200
5Novo Nordisk Investigational SiteBeijingBeijingChina102218
6Novo Nordisk Investigational SiteChongqingChongqingChina400010
7Novo Nordisk Investigational SiteChongQingChongqingChina404000
8Novo Nordisk Investigational SiteFuzhouFujianChina350025
9Novo Nordisk Investigational SiteGuangzhouGuangdongChina510120
10Novo Nordisk Investigational SiteGuangzhouGuangdongChina510150
11Novo Nordisk Investigational SiteHuizhouGuangdongChina516001
12Novo Nordisk Investigational SiteShantouGuangdongChina515065
13Novo Nordisk Investigational SiteCangzhouHebeiChina061000
14Novo Nordisk Investigational SiteHandanHebeiChina056002
15Novo Nordisk Investigational SiteHengshuiHebeiChina053000
16Novo Nordisk Investigational SiteShijiazhuangHebeiChina050000
17Novo Nordisk Investigational SiteZhengzhouHenanChina450003
18Novo Nordisk Investigational SiteShiyanHubeiChina442008
19Novo Nordisk Investigational SiteChangdeHunanChina415003
20Novo Nordisk Investigational SiteChenzhouHunanChina423000
21Novo Nordisk Investigational SiteYueyangHunanChina414000
22Novo Nordisk Investigational SiteChangzhouJiangsuChina213003
23Novo Nordisk Investigational SiteHuai'anJiangsuChina223002
24Novo Nordisk Investigational SiteNanjingJiangsuChina210011
25Novo Nordisk Investigational SiteNanjingJiangsuChina211106
26Novo Nordisk Investigational SiteWuxiJiangsuChina214023
27Novo Nordisk Investigational SiteXuzhouJiangsuChina221002
28Novo Nordisk Investigational SiteZhenjiangJiangsuChina212001
29Novo Nordisk Investigational SiteJiaxingJiangxiChina314001
30Novo Nordisk Investigational SiteNanchangJiangxiChina330006
31Novo Nordisk Investigational SiteChangchunJilinChina130021
32Novo Nordisk Investigational SiteChangchunJilinChina130033
33Novo Nordisk Investigational SiteChangchunJilinChina130041
34Novo Nordisk Investigational SiteYinchuanNingxiaChina750004
35Novo Nordisk Investigational SiteXiningQinghaiChina810001
36Novo Nordisk Investigational SiteXi'anShaanxiChina710004
37Novo Nordisk Investigational SiteJinanShandongChina250013
38Novo Nordisk Investigational SiteJiningShandongChina272029
39Novo Nordisk Investigational SiteQingdaoShandongChina266003
40Novo Nordisk Investigational SitePudong New DistrictShanghaiChina201200
41Novo Nordisk Investigational SiteShanghaiShanghaiChina200025
42Novo Nordisk Investigational SiteShanghaiShanghaiChina200065
43Novo Nordisk Investigational SiteShanghaiShanghaiChina200072
44Novo Nordisk Investigational SiteShanghaiShanghaiChina200240
45Novo Nordisk Investigational SiteShanghaiShanghaiChina200336
46Novo Nordisk Investigational SiteChengduSichuanChina610071
47Novo Nordisk Investigational SiteTianjinTianjinChina300211
48Novo Nordisk Investigational SiteKunmingYunnanChina650032
49Novo Nordisk Investigational SiteChangshaChina410013
50Novo Nordisk Investigational SiteBudapestHungary1032
51Novo Nordisk Investigational SiteNagykanizsaHungary8800
52Novo Nordisk Investigational SiteTatabányaHungary2800
53Novo Nordisk Investigational SiteZalaegerszegHungary8900
54Novo Nordisk Investigational SiteBelgradeSerbia11080
55Novo Nordisk Investigational SiteNisSerbia18000
56Novo Nordisk Investigational SiteTaipeiTaiwan100
57Novo Nordisk Investigational SiteTaipeiTaiwan112
58Novo Nordisk Investigational SiteTaoyuan cityTaiwan333
59Novo Nordisk Investigational SiteDniproUkraine49038
60Novo Nordisk Investigational SiteKhmelnytskyiUkraine29000
61Novo Nordisk Investigational SiteKyivUkraine04114
62Novo Nordisk Investigational SiteMykolaivUkraine54003
63Novo Nordisk Investigational SitePoltavaUkraine36039
64Novo Nordisk Investigational SiteTernopilUkraine46002
65Novo Nordisk Investigational SiteZaporizhiaUkraine69600

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04109547
Other Study ID Numbers:
  • NN9924-4338
  • U1111-1188-1173
  • 2018-002590-22
First Posted:
Sep 30, 2019
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021