PIONEER TEENS

CompletedPhase 3

A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

132

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04596631

Org study IDNN9924-4437

Secondary ID2018-002952-34European Medicines Agency (EudraCT)

Secondary IDU1111-1218-1527World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-10-22actual

Study start2020-11-02actual

Primary completion2025-04-29actual

Study completion2026-02-03actual

Last update posted2026-03-11actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

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

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.

Endpoints (71)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Other (unclassified)

Cardiometabolic biomarkers

Weight & body composition

11 endpoints

Secondary/protocol endpoint

Change from baseline in body mass index (BMI) standard deviation score (SDS)

Time frame:Week 0, week 26

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline in body weight

Time frame:Week 0, week 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline in body weight

Time frame:Week 0, week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Week 0, week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Week 0, week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI SDS

Time frame:Week 0, week 52

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

BMI percentile (age and gender adjusted)

Time frame:Week 0, week 26

descriptive, improvement

Secondary/protocol endpoint

BMI percentile (age and gender adjusted)

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Height velocity

Time frame:At week 26

change from baseline, descriptive

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in FPG

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), American Association of Clinical Endocrinologists (AACE) target

Time frame:At week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c below 7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018

Time frame:At week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), AACE targetat week 26

Time frame:At week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to additional anti-diabetic medication (to support the treatment policy estimand)

Time frame:Week 0 - week 52

time to event, event

Secondary/protocol endpoint

Time to rescue medication (to support the hypothetical estimand)

Time frame:Week 0 - week 52

time to event, event

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change from baseline in systolic blood pressure

Time frame:Week 0, week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from baseline in systolic blood pressure

Time frame:Week 0, week 52

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from baseline in diastolic blood pressure

Time frame:Week 0, week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from baseline in diastolic blood pressure

Time frame:Week 0, week 52

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from baseline in pulse rate

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in pulse rate

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change from pre-dose to post-dose (25 and 40 min) in lactate

Time frame:At week 12

change from baseline, descriptive

Safety / tolerability / PK

21 endpoints

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs) during exposure to trial product

Time frame:Week 0 - week 57

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

Time frame:From randomisation (week 0) to week 26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product

Time frame:Week 0 - week 57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode

Time frame:From randomisation (week 0) to week 26

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product

Time frame:Week 0 - week 57

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change from baseline in amylase

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in amylase

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in lipase

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in lipase

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in calcitonin

Time frame:Week 0, week 26

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in calcitonin

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in thyroid stimulating hormone (TSH/thyrotropin)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in thyroid stimulating hormone (TSH/thyrotropin)

Time frame:Week 0, week 52

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Anti-semaglutide antibody status

Time frame:Week 0 - week 57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Anti-semaglutide antibody titer

Time frame:Up to 57 weeks

Immunogenicity (ADA)

event count, event

Secondary/protocol endpoint

Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide

Time frame:Week 0 to week 57

Immunogenicity (ADA)

event count, event

Secondary/protocol endpoint

Anti-semaglutide antibodies cross reacting with endogenous GLP-1

Time frame:Week 0 to week 57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1

Time frame:Week 0 to week 57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:Week 0 - week 52

descriptive

Secondary/protocol endpoint

Average concentration (Cavg)

Time frame:Week 0 - week 52

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

SNAC plasma concentrations

Time frame:Week 0 - week 52

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

14 endpoints

Secondary/protocol endpoint

Change from baseline in estradiol (for girls)

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in estradiol (for girls)

Time frame:Week 0, week 52

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in testosterone (for boys)

Time frame:Week 0, week 26

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in testosterone (for boys)

Time frame:Week 0, week 52

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in follicle stimulating hormone (FSH)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in follicle stimulating hormone (FSH)

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in luteinizing hormone (LH)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in luteinizing hormone (LH)

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

Time frame:Week 0, week 26

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

Time frame:Week 0, week 52

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Height velocity

Time frame:At week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in bone age assessment, X-ray

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in pubertal assessment (Tanner staging)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change from baseline in pubertal assessment (Tanner staging)

Time frame:Week 0, week 52

change from baseline, descriptive

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Change from baseline in insulin-like growth factor 1 (IGF-1)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in insulin-like growth factor 1 (IGF-1)

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3)

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in prolactin

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in prolactin

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in height SDS

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from pre-dose to post-dose (25 and 40 min) in lactate

Time frame:At week 26

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.