Toggle navigation
Lebanon Clinical Trials Registry
Home
About Us
FAQs
Contact Us
Search Trials
Register
Log in
User Guide
Trial details
You are here
Home
Search Trials
Trial details
Trial details
Efficacy and safety of oral semaglutide versus placebo in children and adolescents with type 2 diabetes
Current status:
Approved
|
Date registered:
03/04/2021
|
Date last updated:
29/03/2021
Trial version(s)
Current: 11/01/2021
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2021014721
Protocol number
NN9924-4437
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
12/01/2021
Primary sponsor
Novo Nordisk A/S
Primary sponsor: Country of origin
Denmark
Public title
Efficacy and safety of oral semaglutide versus placebo in children and adolescents with type 2 diabetes
Acronym
PIONEER TEENS
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
Acronym
PIONEER TEENS
Brief summary of the study: English
PIONEER TEENS (NN9924-4437) will be conducted to confirm the efficacy and safety of oral semaglutide in the paediatric population to address the unmet need for treatment of children and adolescents 10 to <18 years of age with type 2 diabetes. Further, the trial will explore the beta-cell function- preserving effects of oral semaglutide during treatment and after a period of 12 weeks off-trial product following the 52-week treatment period.
Brief summary of the study: Arabic
تهدف هذه الدراسة لمقارنة دوائين لعلاج داء السكّري من النوع الثاني سيماغلوتيد دواء جديد ودواء وهمي سيقوم الباحثون باختبار سيماغلوتيد لمعرفة مدى فعاليته مقارنة بالدواء الوهمي. سبق أن اختبر الباحثون سيماغلوتيد على البالغين. ستختبر الدراسة أيضاً ما إذا كان سيماغلوتيد آمناً للأطفال والمراهقين.
Health conditions/problem studied: Specify
Type two diabetes in paediatric population
Interventions: Specify
Subjects will, after a 2-week screening period, be randomised in a 1:1 manner to receive either oral semaglutide or placebo.
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply: 1. 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. 2. Male or female, aged 10 to <18 years at the day of randomisation 3. Diagnosed with type 2 diabetes mellitus according to the ADA criteria and treated with: • stable metformin dose* or • stable metformin dose* and a stable dose of basal insulin** or • stable dose of basal insulin** *stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening. **stable dose of basal insulin is defined as basal insulin treatment ≥30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed. 4. HbA1c 6.5%−11.0% (47−97 mmol/mol) (both inclusive) 5. Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
10
Key inclusion and exclusion criteria: Age maximum
17
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Previous participation in this trial. Participation is defined as randomisation. Re-screening is allowed, however there must be at least 90 days between screenings. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods, refer to Appendix 5. 4. Receipt of any investigational medicinal product within 30 days before screening. 5. Any disorder, which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol. 6. Any laboratory safety parameter at screening outside the below extended laboratory ranges: • ALT ≥2.5 times the upper normal limit (UNL) • creatinine >UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator • C-peptide <1.5 ng/mL • calcitonin ≥50 ng/L 7. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. 8. History or presence of pancreatitis (acute or chronic). 9. Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG) within 180 days of visit 1, new clinically significant arrhythmias or conduction delays on ECG identified at visit 1. 10. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 82. 11. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 12. Uncontrolled hypertension, treated or untreated, >99th percentile for age and gender in children and adolescents. If “white coat hypertension” is suspected at visit 1 a repeat blood pressure measurement either during visit 1 or at visit 2 prior to other trial related activities is allowed, with the last measurement being conclusive. 13. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening. However, short-term treatment with bolus insulin for a metabolic decompensation/intercurrent illness for a maximum of 14 days prior to the day of visit 1 is allowed. 14. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy documented by an ophthalmologic examination of the retina preferably supported by a fundus photography or optical coherence tomography within the past 90 days prior to screening or in the period between screening and randomisation (visit 2). Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 15. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. 16. Diagnosis of type 1 diabetes 17. Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. 18. Maturity onset diabetes of the young (MODY). 19. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy or gastric bypass surgery).
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
27 EU countries and UK
Name of IMP
Oral Semaglutide
Year of authorization
2020
Month of authorization
4
Type of IMP
Others
Type of IMP: Specify
GLP-1 receptor agonist
Pharmaceutical class
Anti-Diabetic
Therapeutic indication
Type Two Diabetes in paediatric patients
Therapeutic benefit
PIONEER TEENS (NN9924-4437) will be conducted to confirm the efficacy and safety of oral semaglutide in the paediatric population to address the unmet need for treatment of children and adolescents 10 to <18 years of age with type 2 diabetes
Biospecimen retention
Samples without DNA
Biospecimen description
• HbA1c • Fasting glucagon • Fasting insulin • Fasting pro-insulin • Fasting plasma glucose (FPG)1 • Fasting pro-insulin to insulin ratio • Fasting C-peptide • Random C-peptide (i.e. not fasting at visit 1) • Homeostasis model assessment (HOMA-B and HOMA-IR) • Plasma glucose, fasting and non-fasting • C-peptide, fasting and non-fasting • Insulin, fasting and non-fasting • Glucagon, fasting and non-fasting • Cholesterol • High density lipoprotein (HDL) cholesterol • Low density lipoprotein (LDL) cholesterol • Triglycerides • Very low density lipoprotein (VLDL) cholesterol • Erythrocytes • Haematocrit • Haemoglobin • Leucocytes • Thrombocytes • Differential count: eosinophils, basophils, lymphocytes, monocytes, neutrophils • Alanine Aminotransferase (ALT)2 • Albumin • Alkaline phosphatase (ALP) • Amylase • Aspartate Aminotransferase (AST) • Bilirubin (total) • Calcium • Creatine kinase • Creatinine2 • Lipase • Potassium • Sodium • Urea and calcium (albumin corrected urea) • Lactate • Insulin-like growth factor 1 (IGF-1) • Insulin-like growth factor binding protein 3 (IGFBP-3) • Anti-glutamic acid decarboxylase (anti-GAD) antibodies • Insulinoma associated-protein 2 (IA-2) antibodies • Calcitonin • Dehydroepiandrosterone sulphate (DHEAS) • Estradiol (for girls) • Follicle stimulating hormone (FSH) • Luteinizing hormone (LH) • Prolactin • Testosterone (for boys) • Thyroid stimulating hormone (TSH)
Target sample size
132
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
31/03/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
26/03/2025
Recruitment status
Not recruiting
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
It will not be shared
Additional data URL
U1111-1218-1527
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
Novo Nordisk A/S
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Badiaa
Masri
Sin El fil
Lebanon
009611488664
bams@novonordisk.com
Novo Nordisk
Scientific
Rita
Habib
Sin El Fil
Lebanon
009611488664
rteb@novonordisk.com
Novo Nordisk
Scientific
Charles
Saab
Baabda
Lebanon
009613253944
drcsaab@hotmail.com
Chronic Care Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Chronic Care Center
Dr. Charles Saab
Endocrinologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Chronic Care Center
11/12/2020
Michelle Abi Saad
cccmas@chroniccare.org.lb
009615455101
Countries of Recruitment
Name
Mexico
Russian Federation
United States of America
Netherlands
Portugal
Greece
Czech Republic
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
type 2 diabetes
Obesity (E66)
T2D
Interventions
Intervention
Description
Keyword
To confirm superiority of oral semaglutide at the maximum tolerated dose* (3 mg, 7 mg or 14 mg)
confirm the efficacy and safety of oral semaglutide in the paediatric population to address the unmet need for treatment of children and adolescents 10 to <18 years of age with type 2 diabetes. Further, the trial will explore the beta-cell function-preserving effects of oral semaglutide during treatment and after a period of 12 weeks offtrialproduct following the 52-week treatment period.
T2D
Primary Outcomes
Name
Time points
Measure
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and
week 0 to week 26
HbA1c
Key Secondary Outcomes
Name
Time points
Measure
Fasting plasma glucose (FPG) (mmol/L)
week 0 to week 26
FPG
Body mass index (BMI) standard deviation score (SDS)
week 0 to week 26
BMI
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial