A Research Study to Compare a New Medicine Oral Semagluti... | NCT04596631

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

NCT04596631

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 11, 2026Actual

Enrollment

132Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Oral semaglutide
Placebo (semaglutide)

Countries

United States
Australia
Austria
Belgium
Czechia
Greece
India
Israel
Lebanon
Malaysia
Mexico
Morocco
Netherlands
New Zealand
North Macedonia
Portugal
Puerto Rico
Romania
Russia
Taiwan
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1218-1527	Other Identifier	World Health Organization (WHO)
2018-002952-34	Registry Identifier	European Medicines Agency (EudraCT)

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2020Actual

Primary Completion Date

Apr 29, 2025Actual

Completion Date

Feb 3, 2026Actual

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide - max. tolerated dose	Experimental	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.	Drug: Oral semaglutide
Placebo (semaglutide)	Placebo Comparator	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.	Drug: Placebo (semaglutide)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral semaglutide	Drug	Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.	Semaglutide - max. tolerated dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in glycosylated haemoglobin (HbA1c)	Percentage point	Week 0, week 26

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in fasting plasma glucose (FPG)	mmol/L	Week 0, week 26
Change from baseline in body mass index (BMI) standard deviation score (SDS)	SDS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB Ped Endo Children's Hosp		Birmingham	Alabama	35233	United States
Children's Hospital Los Angeles - Endocrinology

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://novonordisk-trials.com

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 29, 2026			May 21, 2026	83
Jun 15, 2026

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases