Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04707469
Registration number
NCT04707469
Ethics application status
Date submitted
12/01/2021
Date registered
13/01/2021
Date last updated
3/04/2024
Titles & IDs
Public title
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Query!
Scientific title
Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
Query!
Secondary ID [1]
0
0
U1111-1247-0210
Query!
Secondary ID [2]
0
0
NN9924-4635
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PIONEER PLUS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Oral semaglutide
Experimental: Oral semaglutide 50 mg - Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).
Experimental: Oral semaglutide 25 mg - Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).
Active Comparator: Oral semaglutide 14 mg - Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).
Treatment: Drugs: Oral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
Query!
Assessment method [1]
0
0
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Query!
Timepoint [1]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [1]
0
0
Change From Baseline in Body Weight (Week 52)
Query!
Assessment method [1]
0
0
Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [1]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [2]
0
0
Change From Baseline in HbA1c (Week 68)
Query!
Assessment method [2]
0
0
Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Query!
Timepoint [2]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [3]
0
0
Change From Week 12 in HbA1c (Week 52)
Query!
Assessment method [3]
0
0
Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Query!
Timepoint [3]
0
0
Week 12, Week 52
Query!
Secondary outcome [4]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
Query!
Assessment method [4]
0
0
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [4]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [5]
0
0
Change From Baseline in FPG (Week 68)
Query!
Assessment method [5]
0
0
Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [5]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [6]
0
0
Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)
Query!
Assessment method [6]
0
0
Percentage of participants who achieved HbA1c <7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [6]
0
0
At week 52
Query!
Secondary outcome [7]
0
0
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
Query!
Assessment method [7]
0
0
Percentage of participants who achieved HbA1c <7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [7]
0
0
At week 68
Query!
Secondary outcome [8]
0
0
Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)
Query!
Assessment method [8]
0
0
Percentage of participants who achieved HbA1c <=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [8]
0
0
At week 52
Query!
Secondary outcome [9]
0
0
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
Query!
Assessment method [9]
0
0
Percentage of participants who achieved HbA1c <=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [9]
0
0
At week 68
Query!
Secondary outcome [10]
0
0
Time to Event Analyses of Rescue Medication
Query!
Assessment method [10]
0
0
Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [10]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [11]
0
0
Change From Baseline in Body Weight (Week 68)
Query!
Assessment method [11]
0
0
Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [11]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [12]
0
0
Percentage Change From Baseline in Body Weight (Week 52)
Query!
Assessment method [12]
0
0
Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [12]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [13]
0
0
Percentage Change From Baseline in Body Weight (Week 68)
Query!
Assessment method [13]
0
0
Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [13]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [14]
0
0
Percentage Change From Week 12 in Body Weight (Week 52)
Query!
Assessment method [14]
0
0
Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [14]
0
0
Week 12, Week 52
Query!
Secondary outcome [15]
0
0
Change From Baseline in Body Mass Index (BMI) (Week 52)
Query!
Assessment method [15]
0
0
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [15]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [16]
0
0
Change From Baseline in BMI (Week 68)
Query!
Assessment method [16]
0
0
Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [16]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [17]
0
0
Change From Baseline in Waist Circumference (Week 52)
Query!
Assessment method [17]
0
0
Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [17]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [18]
0
0
Change From Baseline in Waist Circumference (Week 68)
Query!
Assessment method [18]
0
0
Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [18]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [19]
0
0
Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)
Query!
Assessment method [19]
0
0
Percentage of participants who achieved weight loss >= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [19]
0
0
At week 52
Query!
Secondary outcome [20]
0
0
Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)
Query!
Assessment method [20]
0
0
Percentage of participants who achieved weight loss >= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [20]
0
0
At week 68
Query!
Secondary outcome [21]
0
0
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)
Query!
Assessment method [21]
0
0
Percentage of participants who achieved weight loss >= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [21]
0
0
At week 52
Query!
Secondary outcome [22]
0
0
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
Query!
Assessment method [22]
0
0
Percentage of participants who achieved weight loss >= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [22]
0
0
At week 68
Query!
Secondary outcome [23]
0
0
Change From Baseline in Total Cholesterol (Week 52)
Query!
Assessment method [23]
0
0
Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [23]
0
0
Baseline, Week 52
Query!
Secondary outcome [24]
0
0
Change From Baseline in Total Cholesterol (Week 68)
Query!
Assessment method [24]
0
0
Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [24]
0
0
Baseline, Week 68
Query!
Secondary outcome [25]
0
0
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
Query!
Assessment method [25]
0
0
Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [25]
0
0
Baseline, Week 52
Query!
Secondary outcome [26]
0
0
Change From Baseline in LDL (Week 68)
Query!
Assessment method [26]
0
0
Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [26]
0
0
Baseline, Week 68
Query!
Secondary outcome [27]
0
0
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
Query!
Assessment method [27]
0
0
Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [27]
0
0
Baseline, Week 52
Query!
Secondary outcome [28]
0
0
Change From Baseline in HDL (Week 68)
Query!
Assessment method [28]
0
0
Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [28]
0
0
Baseline, Week 68
Query!
Secondary outcome [29]
0
0
Change From Baseline in Triglycerides (Week 52)
Query!
Assessment method [29]
0
0
Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [29]
0
0
Baseline, Week 52
Query!
Secondary outcome [30]
0
0
Change From Baseline in Triglycerides (Week 68)
Query!
Assessment method [30]
0
0
Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.
Query!
Timepoint [30]
0
0
Baseline, Week 68
Query!
Secondary outcome [31]
0
0
Number of Adverse Events
Query!
Assessment method [31]
0
0
An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [31]
0
0
From baseline (week 0) up to week 73
Query!
Secondary outcome [32]
0
0
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)
Query!
Assessment method [32]
0
0
Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was < 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [32]
0
0
From baseline (week 0) up to week 68
Query!
Secondary outcome [33]
0
0
Change From Baseline in Systolic Blood Pressure (Week 52)
Query!
Assessment method [33]
0
0
Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [33]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [34]
0
0
Change From Baseline in Systolic Blood Pressure (Week 68)
Query!
Assessment method [34]
0
0
Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [34]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [35]
0
0
Change From Baseline in Diastolic Blood Pressure (Week 52)
Query!
Assessment method [35]
0
0
Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [35]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [36]
0
0
Change From Baseline in Diastolic Blood Pressure (Week 68)
Query!
Assessment method [36]
0
0
Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [36]
0
0
Baseline (week 0), week 68
Query!
Secondary outcome [37]
0
0
Change From Baseline in Pulse (Week 52)
Query!
Assessment method [37]
0
0
Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [37]
0
0
Baseline (week 0), week 52
Query!
Secondary outcome [38]
0
0
Change From Baseline in Pulse (Week 68)
Query!
Assessment method [38]
0
0
Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Query!
Timepoint [38]
0
0
Baseline (week 0), week 68
Query!
Eligibility
Key inclusion criteria
- Male or female, age above or equal to 18 years at the time of signing informed
consent.
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of
screening.
- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- BMI equal to or above 25 kg/m^2
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following
treatment regimens:
- No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a
*:
- Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
- Sulfonylureas (SU) (equal to or above half of the maximum approved dose according
to local label or maximum tolerated or effective dose).
- Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local
label).
- Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be
willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Treatment with any medication indicated for the treatment of diabetes or obesity other
than stated in the inclusion criteria within the past 90 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.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of
below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving
global outcomes (KDIGO 2012) classification.
- 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/01/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/03/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1606
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [2]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [3]
0
0
Core Research Centre - Milton
Query!
Recruitment hospital [4]
0
0
South Australian Endocrine Research - Keswick
Query!
Recruitment hospital [5]
0
0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Query!
Recruitment hospital [6]
0
0
Barwon Health (The Geelong Hospital) - Geelong
Query!
Recruitment postcode(s) [1]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [2]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [3]
0
0
4064 - Milton
Query!
Recruitment postcode(s) [4]
0
0
5035 - Keswick
Query!
Recruitment postcode(s) [5]
0
0
5046 - Oaklands Park
Query!
Recruitment postcode(s) [6]
0
0
3220 - Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Montana
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Dakota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Tennessee
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Washington
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Blagoevgrad
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Lom
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Pazardzhik
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Pleven
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Plovdiv
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Sliven
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Smolyan
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Sofia
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Varna
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Vratsa
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Yambol
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Alberta
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
New Brunswick
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Ontario
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Quebec
Query!
Country [43]
0
0
Croatia
Query!
State/province [43]
0
0
Grad Zagreb
Query!
Country [44]
0
0
Croatia
Query!
State/province [44]
0
0
Primorsko - Goranska Županija
Query!
Country [45]
0
0
Croatia
Query!
State/province [45]
0
0
Osijek
Query!
Country [46]
0
0
Croatia
Query!
State/province [46]
0
0
Slavonski Brod
Query!
Country [47]
0
0
Croatia
Query!
State/province [47]
0
0
Zagreb
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Chomutov
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Holešov
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Plzen 3
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Praha
Query!
Country [52]
0
0
Estonia
Query!
State/province [52]
0
0
Pärnu
Query!
Country [53]
0
0
Estonia
Query!
State/province [53]
0
0
Tallinn
Query!
Country [54]
0
0
Estonia
Query!
State/province [54]
0
0
Tartu
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Berlin
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Essen
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Falkensee
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Hamburg
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Münster
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Oldenburg in Holstein
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Rehlingen-Siersburg
Query!
Country [62]
0
0
Hungary
Query!
State/province [62]
0
0
Komárom-Esztergom
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Budapest
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Debrecen
Query!
Country [65]
0
0
Hungary
Query!
State/province [65]
0
0
Pécs
Query!
Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Szombathely
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Székesfehérvár
Query!
Country [68]
0
0
India
Query!
State/province [68]
0
0
A.p.
Query!
Country [69]
0
0
India
Query!
State/province [69]
0
0
Andhra Pradesh
Query!
Country [70]
0
0
India
Query!
State/province [70]
0
0
Delhi
Query!
Country [71]
0
0
India
Query!
State/province [71]
0
0
Gujarat
Query!
Country [72]
0
0
India
Query!
State/province [72]
0
0
Haryana
Query!
Country [73]
0
0
India
Query!
State/province [73]
0
0
Karnatka
Query!
Country [74]
0
0
India
Query!
State/province [74]
0
0
Kerala
Query!
Country [75]
0
0
India
Query!
State/province [75]
0
0
Maharashtra
Query!
Country [76]
0
0
India
Query!
State/province [76]
0
0
New Delhi
Query!
Country [77]
0
0
India
Query!
State/province [77]
0
0
Punjab
Query!
Country [78]
0
0
India
Query!
State/province [78]
0
0
Tamil Nadu
Query!
Country [79]
0
0
India
Query!
State/province [79]
0
0
Telengana
Query!
Country [80]
0
0
India
Query!
State/province [80]
0
0
Uttar Pradesh
Query!
Country [81]
0
0
India
Query!
State/province [81]
0
0
West Bengal
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Lubelski
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Lubuskie
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Podlaskie Voivodeship
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Podlaskie
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Wielkopolskie Voivodeship
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Bialystok
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Elblag
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Gdansk
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Krakow
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Lodz
Query!
Country [92]
0
0
Poland
Query!
State/province [92]
0
0
Poznan
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Radom
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Warszawa
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Wroclaw
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Zabrze
Query!
Country [97]
0
0
Puerto Rico
Query!
State/province [97]
0
0
Manati
Query!
Country [98]
0
0
Slovakia
Query!
State/province [98]
0
0
Bardejov
Query!
Country [99]
0
0
Slovakia
Query!
State/province [99]
0
0
Hnusta
Query!
Country [100]
0
0
Slovakia
Query!
State/province [100]
0
0
Kezmarok
Query!
Country [101]
0
0
Slovakia
Query!
State/province [101]
0
0
Kralovsky Chlmec
Query!
Country [102]
0
0
Slovakia
Query!
State/province [102]
0
0
Lucenec
Query!
Country [103]
0
0
Slovakia
Query!
State/province [103]
0
0
Presov
Query!
Country [104]
0
0
Slovakia
Query!
State/province [104]
0
0
Rimavska Sobota
Query!
Country [105]
0
0
Slovakia
Query!
State/province [105]
0
0
Sabinov
Query!
Country [106]
0
0
Slovakia
Query!
State/province [106]
0
0
Spisska Nova Ves
Query!
Country [107]
0
0
Slovenia
Query!
State/province [107]
0
0
Celje
Query!
Country [108]
0
0
Slovenia
Query!
State/province [108]
0
0
Koper
Query!
Country [109]
0
0
Slovenia
Query!
State/province [109]
0
0
Ljubljana
Query!
Country [110]
0
0
Slovenia
Query!
State/province [110]
0
0
Maribor
Query!
Country [111]
0
0
Slovenia
Query!
State/province [111]
0
0
Nova Gorica
Query!
Country [112]
0
0
Taiwan
Query!
State/province [112]
0
0
Taichung City
Query!
Country [113]
0
0
Taiwan
Query!
State/province [113]
0
0
Tainan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study compares three doses of once daily semaglutide tablets in people with type 2
diabetes who were previously treated with other oral anti-diabetic medicines. Participants
will be initiated on the lowest starting dose of 3 mg and gradually increased until they
reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final
three doses will be randomized (i.e., decided by chance). Participants will be administered
one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding
or planning to become pregnant during the study period. Women who can get pregnant will be
checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg)
are approved for the treatment of type 2 diabetes in the US, in the EU and in some other
countries, under the brand name Rybelsus®.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04707469
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Transparency (dept. 1452)
Query!
Address
0
0
Novo Nordisk A/S
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04707469
Download to PDF