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A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes (PIONEER 12)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Oral semaglutide

Sitagliptin

Placebo (oral semaglutide)

Placebo (sitagliptin)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 informed consent.

For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent

Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening.
HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).
Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening

Exclusion Criteria:

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 (adequate contraceptive measure as required by local regulation or practice).
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 and randomisation.
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).
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Oral semaglutide 3 mg and placebo (sitagliptin)

Oral semaglutide 7 mg and placebo (sitagliptin)

Oral semaglutide 14 mg and placebo (sitagliptin)

Sitagliptin 100 mg and placebo (oral semaglutide)

Arm Description

Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks

Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks

Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks

Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks

Outcomes

Primary Outcome Measures

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)

Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and 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. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.

Secondary Outcome Measures

Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)

Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) 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 and 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.

Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Change from baseline 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 and 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.

Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)

Change from baseline in 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 and 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.

Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)

Number of participants who achieved HbA1c <7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C <7.0 (53 mmol/mol) (ADA target) is presented in category "No". 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 and 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.

Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) 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 and 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.

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)

Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) 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 and 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.

Time to Rescue Medication

Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. 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 and 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.

Change From Baseline to Week 26 in Body Weight (Kilogram [kg])

Change in body weight from baseline to week 26 in kg 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 and 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.

Percentage Change From Baseline to Week 26 in Body Weight

Percentage change from baseline to week 26 in body weight 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 and 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.

Change From Baseline to Week 26 in Body Mass Index (BMI)

Change from baseline in BMI 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 and 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.

Change From Baseline to Week 26 in Waist Circumference

Change from baseline in waist circumference 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 and 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Change from baseline in total cholesterol (measured in mmol/L) 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Change from baseline in LDL cholesterol (measured in mmol/L) 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Change from baseline in VLDL cholesterol (measured in mmol/L) 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Change from baseline in HDL Cholesterol (measured in mmol/L) 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Change from baseline in triglycerides (measured in mmol/L) 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.

Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)

Change from baseline in free fatty acids (measured in mmol/L) 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.

Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

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). A positive change score indicates an improvement since baseline. 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 end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication.

Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.

Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)

Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.

Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)

Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.

Number of Participants Who Achieved 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)

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 In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.

Number of Participants Who Achieved 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)

Number of participants who achieved 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) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.

Number of Treatment-emergent Adverse Events During Exposure to Trial Product

An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value < 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils

Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)

Change from baseline in Haematocrit at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)

Change from baseline in Haemoglobin at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)

Change from baseline in Leucocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)

Change from baseline in thrombocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)

Change from baseline in calcium (total) (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)

Change from baseline in potassium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)

Change from baseline in sodium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)

Change from baseline in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)

Change from baseline in Albumin (measured in grams per deciliter [g/dL]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)

Change from baseline in calcitonin (measured in picograms per milliliter [pg/ml]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Vital Signs: Pulse Rate

Change from baseline in pulse rate is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure

Change from baseline in systolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure

Change from baseline in diastolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Electrocardiogram (ECG) Category

Change from baseline in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Physical Examination Category

The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Change From Baseline to Week 26 in Eye Examination Category

The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value < 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.

Full Information

NCT ID

NCT04017832

First Posted

July 11, 2019

Last Updated

September 28, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04017832

Brief Title

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

Acronym

PIONEER 12

Official Title

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

July 29, 2019 (Actual)

Primary Completion Date

October 27, 2021 (Actual)

Study Completion Date

October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Allocation

Randomized

Enrollment

1441 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral semaglutide 3 mg and placebo (sitagliptin)

Arm Type

Experimental

Arm Description

Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks

Arm Title

Oral semaglutide 7 mg and placebo (sitagliptin)

Arm Type

Experimental

Arm Description

Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks

Arm Title

Oral semaglutide 14 mg and placebo (sitagliptin)

Arm Type

Experimental

Arm Description

Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks

Arm Title

Sitagliptin 100 mg and placebo (oral semaglutide)

Arm Type

Experimental

Arm Description

Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks

Intervention Type

Drug

Intervention Name(s)

Oral semaglutide

Intervention Description

Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Intervention Description

Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets

Intervention Type

Drug

Intervention Name(s)

Placebo (oral semaglutide)

Intervention Description

Placebo tablet to be taken first thing in the morning

Intervention Type

Drug

Intervention Name(s)

Placebo (sitagliptin)

Intervention Description

Placebo tablet to be taken 30 minutes after oral semaglutide

Primary Outcome Measure Information:

Title

Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)

Description

Time Frame

From baseline to week 26

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)

Description

Time Frame

From baseline to week 26

Title

Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)

Description

Time Frame

At week 26

Title

Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Description

Time Frame

At week 26

Title

Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)

Description

Time Frame

At week 26

Title

Time to Rescue Medication

Description

Time Frame

From baseline to week 31

Title

Change From Baseline to Week 26 in Body Weight (Kilogram [kg])

Description

Time Frame

From baseline to week 26

Title

Percentage Change From Baseline to Week 26 in Body Weight

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Body Mass Index (BMI)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Waist Circumference

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

Description

Time Frame

From baseline to week 26

Title

Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)

Description

Time Frame

At week 26

Title

Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)

Description

Time Frame

At week 26

Title

Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)

Description

Time Frame

At week 26

Title

Description

Time Frame

At week 26

Title

Number of Participants Who Achieved 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)

Description

Time Frame

At week 26

Title

Number of Treatment-emergent Adverse Events During Exposure to Trial Product

Description

Time Frame

From baseline to week 31

Title

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Description

Time Frame

From baseline to week 31

Title

Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Vital Signs: Pulse Rate

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure

Description

Time Frame

From baseline to week 26

Title

Change From Baseline to Week 26 in Electrocardiogram (ECG) Category

Description

Time Frame

From baseline to week 26

Title

Physical Examination Category

Description

Time Frame

Baseline and week 26

Title

Change From Baseline to Week 26 in Eye Examination Category

Description

Time Frame

From baseline to week 26

Title

Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product

Description

Time Frame

From baseline to week 31

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening. HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive). Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening Exclusion Criteria: 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 (adequate contraceptive measure as required by local regulation or practice). 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 and randomisation. 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). Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Algiers

ZIP/Postal Code

16000

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Algiers

ZIP/Postal Code

16003

Country

Algeria

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90430-001

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-000

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-200

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230001

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230061

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100144

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

101200

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400010

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350025

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Quanzhou

State/Province

Fujian

ZIP/Postal Code

362000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Foshan

State/Province

Guangdong

ZIP/Postal Code

528399

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

511400

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Huizhou

State/Province

Guangdong

ZIP/Postal Code

516001

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shantou

State/Province

Guangdong

ZIP/Postal Code

515065

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Cangzhou

State/Province

Hebei

ZIP/Postal Code

061000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hengshui

State/Province

Hebei

ZIP/Postal Code

053000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Kaifeng

State/Province

Henan

ZIP/Postal Code

475000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Luoyang

State/Province

Henan

ZIP/Postal Code

471003

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450004

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shiyan

State/Province

Hubei

ZIP/Postal Code

442008

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430034

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410018

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Chenzhou

State/Province

Hunan

ZIP/Postal Code

423000

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hengyang

State/Province

Hunan

ZIP/Postal Code

421001

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Zhuzhou

State/Province

Hunan

ZIP/Postal Code

412007

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changzhou

State/Province

Jiangsu

ZIP/Postal Code

213003

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210011

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

211106

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

211166

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215004

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Wuxi

State/Province

Jiangsu

ZIP/Postal Code

214023

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221002

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Zhenjiang

State/Province

Jiangsu

ZIP/Postal Code

212001

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Pingxiang

State/Province

Jiangxi

ZIP/Postal Code

337055

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130033

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130041

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Yinchuan

State/Province

Ningxia

ZIP/Postal Code

750004

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Xining

State/Province

Qinghai

ZIP/Postal Code

810007

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710004

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250013

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266003

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Weifang

State/Province

Shandong

ZIP/Postal Code

261041

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Pudong New District

State/Province

Shanghai

ZIP/Postal Code

201200

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200065

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200072

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200120

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200240

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200336

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300211

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650032

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650101

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

63900

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Chrudim

ZIP/Postal Code

537 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Liberec

ZIP/Postal Code

46001

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

Novo Nordisk Investigational Site

City

Oradea

State/Province

Bihor

ZIP/Postal Code

410025

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Oradea

State/Province

Bihor

ZIP/Postal Code

410151

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300456

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bucharest

ZIP/Postal Code

13682

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Oradea

ZIP/Postal Code

410169

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Arcadia

State/Province

Gauteng

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1812

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Kempton Park

State/Province

Gauteng

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Soshanguve

State/Province

Gauteng

ZIP/Postal Code

0152

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Brits

State/Province

North West

ZIP/Postal Code

0250

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Kuilsriver

State/Province

Western Cape

ZIP/Postal Code

7580

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Alberton

ZIP/Postal Code

1449

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Novo Nordisk Investigational Site

City

Taoyuan city

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Learn more about this trial

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

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A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes (PIONEER 12)

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial