Clinical Trials List
Protocol NumberNN9924-4338
NCT Number(ClinicalTrials.gov Identfier)NCT04109547
2019-08-01 - 2022-03-31
Phase III
Terminated3
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
PIONEER 11 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
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Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
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Sponsor
Novo Nordisk A/S
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黃瓊慧 Division of Endocrinology
- 陳怡文 Division of Endocrinology
- 王誌慶 Division of Endocrinology
- Chih-Yiu Tsai Division of Endocrinology
- 林怡瑄 Division of Endocrinology
- Jia-Hong Lin Division of Endocrinology
- 洪士淵 Division of Endocrinology
- Wen-Cong Lu Division of Endocrinology
- 林承緯 Division of Endocrinology
- 周建安 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳崇輝 醫師 Division of Endocrinology
- Chun-Jui Huang Division of Endocrinology
- 蘇郁文 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
type 2 diabetes mellitus
Objectives
Primary objective
-To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus
once-daily placebo on glycaemic control in subjects with T2D treated with diet and exercise only.
Secondary objectives
-To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus
once-daily placebo on body weight in subjects with T2D treated with diet and exercise only.
-To compare the safety and tolerability of three once-daily dose levels of oral semaglutide (3, 7 and
14 mg) versus once-daily placebo in subjects with T2D treated with diet and exercise only
Test Drug
Semaglutide Tablets
Active Ingredient
Semaglutide
Dosage Form
Tablets
Dosage
3 mg / 7 mg / 14 mg
Endpoints
Primary endpoint
Change from baseline to week 26 in HbA1c
Secondary endpoints
Change from baseline to week 26 in body weight (kg)
Change from baseline to week 26 in:
Fasting plasma glucose (FPG)
7-point self-measured plasma glucose (SMPG) profile
- Mean 7-point profile
- Mean postprandial increment (over all meals)
Number of treatment-emergent adverse events (TEAEs) during exposure to trial product,
assessed up to approximately 31 weeks
Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes
during exposure to trial product, assessed up to approximately 31 weeks
Change from baseline to week 26 in HbA1c
Secondary endpoints
Change from baseline to week 26 in body weight (kg)
Change from baseline to week 26 in:
Fasting plasma glucose (FPG)
7-point self-measured plasma glucose (SMPG) profile
- Mean 7-point profile
- Mean postprandial increment (over all meals)
Number of treatment-emergent adverse events (TEAEs) during exposure to trial product,
assessed up to approximately 31 weeks
Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes
during exposure to trial product, assessed up to approximately 31 weeks
Inclution Criteria
1. 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.
2. 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.
3. Diagnosed with type 2 diabetes mellitus.
4. HbA1c between 7.0-10.0% (53 -86 mmol/mol) (both inclusive).
procedures that are carried out as part of the trial, including activities to determine suitability
for the trial.
2. 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.
3. Diagnosed with type 2 diabetes mellitus.
4. HbA1c between 7.0-10.0% (53 -86 mmol/mol) (both inclusive).
Exclusion Criteria
1. Known or suspected hypersensitivity to trial products or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. 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.
4. Receipt of any investigational medicinal product within 90 days before screening.
5. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
6. 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.
7. History or presence of pancreatitis (acute or chronic).
8. 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).
9. 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.
10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
11. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
12. Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73
m
2
as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
13. Subjects with alanine aminotransferase (ALT) > 2.5 x upper limit of the normal (ULN).
14. Treatment with any medication for the indication of diabetes or obesity in a period of 60 days
before the day of screening. However, short-term insulin treatment for a maximum of 14 days
prior to the day of screening is allowed.
15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown or
unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may,
at the investigator’s discretion, be continued throughout the trial.
16. 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.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. 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.
4. Receipt of any investigational medicinal product within 90 days before screening.
5. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
6. 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.
7. History or presence of pancreatitis (acute or chronic).
8. 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).
9. 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.
10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
11. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
12. Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73
m
2
as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
13. Subjects with alanine aminotransferase (ALT) > 2.5 x upper limit of the normal (ULN).
14. Treatment with any medication for the indication of diabetes or obesity in a period of 60 days
before the day of screening. However, short-term insulin treatment for a maximum of 14 days
prior to the day of screening is allowed.
15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown or
unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may,
at the investigator’s discretion, be continued throughout the trial.
16. 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.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
520 participants
