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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04596631




Registration number
NCT04596631
Ethics application status
Date submitted
16/10/2020
Date registered
22/10/2020

Titles & IDs
Public title
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
Scientific title
Efficacy and Safety of Oral Semaglutide Versus Placebo Both in Combination With Metformin and/or Basal Insulin in Children and Adolescents With Type 2 Diabetes
Secondary ID [1] 0 0
U1111-1218-1527
Secondary ID [2] 0 0
NN9924-4437
Universal Trial Number (UTN)
Trial acronym
PIONEER TEENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral semaglutide
Treatment: Drugs - Placebo (semaglutide)

Experimental: Semaglutide - max. tolerated dose - Participants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.

Placebo comparator: Placebo (semaglutide) - Participants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.


Treatment: Drugs: Oral semaglutide
Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.

Treatment: Drugs: Placebo (semaglutide)
Placebo treatment for 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in glycosylated haemoglobin (HbA1c)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change from baseline in fasting plasma glucose (FPG)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Change from baseline in body mass index (BMI) standard deviation score (SDS)
Timepoint [2] 0 0
Week 0, week 26
Secondary outcome [3] 0 0
Change from baseline in glycosylated haemoglobin (HbA1c)
Timepoint [3] 0 0
Week 0, week 52
Secondary outcome [4] 0 0
Change from baseline in FPG
Timepoint [4] 0 0
Week 0, week 52
Secondary outcome [5] 0 0
Change from baseline in body weight
Timepoint [5] 0 0
Week 0, week 26
Secondary outcome [6] 0 0
Change from baseline in body weight
Timepoint [6] 0 0
Week 0, week 52
Secondary outcome [7] 0 0
Relative change from baseline in body weight
Timepoint [7] 0 0
Week 0, week 26
Secondary outcome [8] 0 0
Relative change from baseline in body weight
Timepoint [8] 0 0
Week 0, week 52
Secondary outcome [9] 0 0
Change from baseline in waist circumference
Timepoint [9] 0 0
Week 0, week 26
Secondary outcome [10] 0 0
Change from baseline in waist circumference
Timepoint [10] 0 0
Week 0, week 52
Secondary outcome [11] 0 0
Change from baseline in BMI SDS
Timepoint [11] 0 0
Week 0, week 52
Secondary outcome [12] 0 0
BMI percentile (age and gender adjusted)
Timepoint [12] 0 0
Week 0, week 26
Secondary outcome [13] 0 0
BMI percentile (age and gender adjusted)
Timepoint [13] 0 0
Week 0, week 52
Secondary outcome [14] 0 0
Change from baseline in systolic blood pressure
Timepoint [14] 0 0
Week 0, week 26
Secondary outcome [15] 0 0
Change from baseline in systolic blood pressure
Timepoint [15] 0 0
Week 0, week 52
Secondary outcome [16] 0 0
Change from baseline in diastolic blood pressure
Timepoint [16] 0 0
Week 0, week 26
Secondary outcome [17] 0 0
Change from baseline in diastolic blood pressure
Timepoint [17] 0 0
Week 0, week 52
Secondary outcome [18] 0 0
HbA1c below 7.0% (53 mmol/mol) (yes/no), American Diabetes Association (ADA) target and International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines from 2018
Timepoint [18] 0 0
At week 26
Secondary outcome [19] 0 0
HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), American Association of Clinical Endocrinologists (AACE) target
Timepoint [19] 0 0
At week 26
Secondary outcome [20] 0 0
HbA1c below 7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018
Timepoint [20] 0 0
At week 52
Secondary outcome [21] 0 0
HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), AACE targetat week 26
Timepoint [21] 0 0
At week 52
Secondary outcome [22] 0 0
Time to additional anti-diabetic medication (to support the treatment policy estimand)
Timepoint [22] 0 0
Week 0 - week 52
Secondary outcome [23] 0 0
Time to rescue medication (to support the hypothetical estimand)
Timepoint [23] 0 0
Week 0 - week 52
Secondary outcome [24] 0 0
Number of treatment-emergent adverse events (TEAEs) during exposure to trial product
Timepoint [24] 0 0
Week 0 - week 57
Secondary outcome [25] 0 0
Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Timepoint [25] 0 0
From randomisation (week 0) to week 26
Secondary outcome [26] 0 0
Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product
Timepoint [26] 0 0
Week 0 - week 57
Secondary outcome [27] 0 0
Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode
Timepoint [27] 0 0
From randomisation (week 0) to week 26
Secondary outcome [28] 0 0
Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product
Timepoint [28] 0 0
Week 0 - week 57
Secondary outcome [29] 0 0
Change from baseline in amylase
Timepoint [29] 0 0
Week 0, week 26
Secondary outcome [30] 0 0
Change from baseline in amylase
Timepoint [30] 0 0
Week 0, week 52
Secondary outcome [31] 0 0
Change from baseline in lipase
Timepoint [31] 0 0
Week 0, week 26
Secondary outcome [32] 0 0
Change from baseline in lipase
Timepoint [32] 0 0
Week 0, week 52
Secondary outcome [33] 0 0
Change from baseline in insulin-like growth factor 1 (IGF-1)
Timepoint [33] 0 0
Week 0, week 26
Secondary outcome [34] 0 0
Change from baseline in insulin-like growth factor 1 (IGF-1)
Timepoint [34] 0 0
Week 0, week 52
Secondary outcome [35] 0 0
Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3)
Timepoint [35] 0 0
Week 0, week 26
Secondary outcome [36] 0 0
Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3)
Timepoint [36] 0 0
Week 0, week 52
Secondary outcome [37] 0 0
Change from baseline in calcitonin
Timepoint [37] 0 0
Week 0, week 26
Secondary outcome [38] 0 0
Change from baseline in calcitonin
Timepoint [38] 0 0
Week 0, week 52
Secondary outcome [39] 0 0
Change from baseline in estradiol (for girls)
Timepoint [39] 0 0
Week 0, week 26
Secondary outcome [40] 0 0
Change from baseline in estradiol (for girls)
Timepoint [40] 0 0
Week 0, week 52
Secondary outcome [41] 0 0
Change from baseline in testosterone (for boys)
Timepoint [41] 0 0
Week 0, week 26
Secondary outcome [42] 0 0
Change from baseline in testosterone (for boys)
Timepoint [42] 0 0
Week 0, week 52
Secondary outcome [43] 0 0
Change from baseline in prolactin
Timepoint [43] 0 0
Week 0, week 26
Secondary outcome [44] 0 0
Change from baseline in prolactin
Timepoint [44] 0 0
Week 0, week 52
Secondary outcome [45] 0 0
Change from baseline in thyroid stimulating hormone (TSH/thyrotropin)
Timepoint [45] 0 0
Week 0, week 26
Secondary outcome [46] 0 0
Change from baseline in thyroid stimulating hormone (TSH/thyrotropin)
Timepoint [46] 0 0
Week 0, week 52
Secondary outcome [47] 0 0
Change from baseline in follicle stimulating hormone (FSH)
Timepoint [47] 0 0
Week 0, week 26
Secondary outcome [48] 0 0
Change from baseline in follicle stimulating hormone (FSH)
Timepoint [48] 0 0
Week 0, week 52
Secondary outcome [49] 0 0
Change from baseline in luteinizing hormone (LH)
Timepoint [49] 0 0
Week 0, week 26
Secondary outcome [50] 0 0
Change from baseline in luteinizing hormone (LH)
Timepoint [50] 0 0
Week 0, week 52
Secondary outcome [51] 0 0
Change from baseline in dehydroepiandrosterone sulfate (DHEAS)
Timepoint [51] 0 0
Week 0, week 26
Secondary outcome [52] 0 0
Change from baseline in dehydroepiandrosterone sulfate (DHEAS)
Timepoint [52] 0 0
Week 0, week 52
Secondary outcome [53] 0 0
Anti-semaglutide antibody status
Timepoint [53] 0 0
Week 0 - week 57
Secondary outcome [54] 0 0
Anti-semaglutide antibody titer
Timepoint [54] 0 0
Up to 57 weeks
Secondary outcome [55] 0 0
Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide
Timepoint [55] 0 0
Week 0 to week 57
Secondary outcome [56] 0 0
Anti-semaglutide antibodies cross reacting with endogenous GLP-1
Timepoint [56] 0 0
Week 0 to week 57
Secondary outcome [57] 0 0
Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1
Timepoint [57] 0 0
Week 0 to week 57
Secondary outcome [58] 0 0
Height velocity
Timepoint [58] 0 0
At week 26
Secondary outcome [59] 0 0
Height velocity
Timepoint [59] 0 0
At week 52
Secondary outcome [60] 0 0
Change from baseline in height SDS
Timepoint [60] 0 0
Week 0, week 26
Secondary outcome [61] 0 0
Change from baseline in bone age assessment, X-ray
Timepoint [61] 0 0
Week 0, week 52
Secondary outcome [62] 0 0
Change from baseline in pubertal assessment (Tanner staging)
Timepoint [62] 0 0
Week 0, week 26
Secondary outcome [63] 0 0
Change from baseline in pubertal assessment (Tanner staging)
Timepoint [63] 0 0
Week 0, week 52
Secondary outcome [64] 0 0
Change from baseline in pulse rate
Timepoint [64] 0 0
Week 0, week 26
Secondary outcome [65] 0 0
Change from baseline in pulse rate
Timepoint [65] 0 0
Week 0, week 52
Secondary outcome [66] 0 0
Change from pre-dose to post-dose (25 and 40 min) in lactate
Timepoint [66] 0 0
At week 12
Secondary outcome [67] 0 0
Change from pre-dose to post-dose (25 and 40 min) in lactate
Timepoint [67] 0 0
At week 26
Secondary outcome [68] 0 0
Apparent clearance (CL/F)
Timepoint [68] 0 0
Week 0 - week 52
Secondary outcome [69] 0 0
Average concentration (Cavg)
Timepoint [69] 0 0
Week 0 - week 52
Secondary outcome [70] 0 0
SNAC plasma concentrations
Timepoint [70] 0 0
Week 0 - week 52

Eligibility
Key inclusion criteria
* Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject 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, aged 10 to below 18 years at the day of randomisation
* HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive)
* Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
* stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or
* stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or
* stable dose of basal insulin
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of type 1 diabetes
* Maturity onset diabetes of the young (MODY)
* Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/02/2026
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Westmead Children's Hospital- The Clinical Research Centre - Westmead
Recruitment hospital [2] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [3] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment hospital [4] 0 0
Perth Children's' Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Czechia
State/province [14] 0 0
Ostrava-Poruba
Country [15] 0 0
Greece
State/province [15] 0 0
Attica
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Greece
State/province [17] 0 0
Haidari-Athens
Country [18] 0 0
Greece
State/province [18] 0 0
Ioannina
Country [19] 0 0
Greece
State/province [19] 0 0
Lamia
Country [20] 0 0
Greece
State/province [20] 0 0
Larissa
Country [21] 0 0
Greece
State/province [21] 0 0
Penteli, Athens
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloniki
Country [23] 0 0
India
State/province [23] 0 0
Andhra Pradesh
Country [24] 0 0
India
State/province [24] 0 0
Maharashtra
Country [25] 0 0
India
State/province [25] 0 0
New Delhi
Country [26] 0 0
India
State/province [26] 0 0
Rajasthan
Country [27] 0 0
India
State/province [27] 0 0
Telangana
Country [28] 0 0
India
State/province [28] 0 0
West Bengal
Country [29] 0 0
India
State/province [29] 0 0
Thriruvananthapuram
Country [30] 0 0
Israel
State/province [30] 0 0
Beer Sheva
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Lebanon
State/province [32] 0 0
Hazmieh
Country [33] 0 0
Malaysia
State/province [33] 0 0
Wilayah Persekutuan Kuala Lumpur
Country [34] 0 0
Malaysia
State/province [34] 0 0
Kuala Lumpur
Country [35] 0 0
Malaysia
State/province [35] 0 0
Putrajaya
Country [36] 0 0
Mexico
State/province [36] 0 0
Puebla
Country [37] 0 0
Morocco
State/province [37] 0 0
Rabat
Country [38] 0 0
Netherlands
State/province [38] 0 0
Almere
Country [39] 0 0
Netherlands
State/province [39] 0 0
Den Bosch
Country [40] 0 0
New Zealand
State/province [40] 0 0
Grafton
Country [41] 0 0
North Macedonia
State/province [41] 0 0
Skopje
Country [42] 0 0
Portugal
State/province [42] 0 0
Lisboa
Country [43] 0 0
Portugal
State/province [43] 0 0
Vila Nova de Gaia
Country [44] 0 0
Puerto Rico
State/province [44] 0 0
Ponce
Country [45] 0 0
Romania
State/province [45] 0 0
Brasov
Country [46] 0 0
Romania
State/province [46] 0 0
Bucharest
Country [47] 0 0
Romania
State/province [47] 0 0
Constanta
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Omsk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Tomsk
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taipei
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taoyuan
Country [52] 0 0
Ukraine
State/province [52] 0 0
Dnipro
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kharkiv
Country [54] 0 0
Ukraine
State/province [54] 0 0
Kyiv
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
clinicaltrials@novonordisk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04596631