Clinical Trials List
Protocol NumberNN9924-4309
NCT Number(ClinicalTrials.gov Identfier)NCT04017832
2019-08-20 - 2022-03-01
Phase III
Terminated4
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 12 Multi-regional clinical trial: Efficacy and safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes mellitus treated with metformin
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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
- Wen-Cong Lu Division of Endocrinology
- 林承緯 Division of Endocrinology
- 周建安 Division of Endocrinology
- 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
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 吳崇暉 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
Diabetes Mellitus, Type 2
Objectives
Primary objective
To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus
sitagliptin 100 mg once-daily, both in combination with metformin, on glycaemic control in
subjects with T2D.
Secondary objectives
To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus
sitagliptin 100 mg once-daily, both in combination with metformin, on body weight in subjects with
T2D.
To compare the safety and tolerability of three once-daily dose levels of oral semaglutide (3, 7 and
14 mg) versus sitagliptin 100 mg once-daily, both in combination with metformin, in subjects with
T2D.
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 HbA1c
Secondary endpoints
Change from baseline to week 26 in body weight (kg)
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
informed consent.
For Taiwan only: Male or female, age above or equal to 20 years at the time of signing
informed consent.
3. Diagnosed with type 2 diabetes mellitus ≥ 60 days prior to day of screening.
4. HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).
5. Stable daily dose of metformin (≥ 1500 mg or maximum tolerated dose as documented in the
subject medical record) ≥ 60 days prior to day of screening.
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
informed consent.
For Taiwan only: Male or female, age above or equal to 20 years at the time of signing
informed consent.
3. Diagnosed with type 2 diabetes mellitus ≥ 60 days prior to day of screening.
4. HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).
5. Stable daily dose of metformin (≥ 1500 mg or maximum tolerated dose as documented in the
subject medical record) ≥ 60 days prior to day of screening.
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 a highly effective contraceptive method.
For more information on requirements, see Appendix C
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 and
randomisation.
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 m2
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 once-weekly Glucagon-like peptide 1 (GLP-1) receptor agonist or
thiazolidinedione within the past 90 days prior to the day of screening.
15. Treatment with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria within the past 60 days prior to the day of screening. However, short-term
insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
16. 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
17. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a
digital fundus photography camera specified for non-dilated examination
18. 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 a highly effective contraceptive method.
For more information on requirements, see Appendix C
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 and
randomisation.
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 m2
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 once-weekly Glucagon-like peptide 1 (GLP-1) receptor agonist or
thiazolidinedione within the past 90 days prior to the day of screening.
15. Treatment with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria within the past 60 days prior to the day of screening. However, short-term
insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
16. 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
17. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a
digital fundus photography camera specified for non-dilated examination
18. 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
70 participants
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Global
1444 participants
