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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Oral semaglutide

Placebo (semaglutide)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide - max. tolerated dose

Placebo (semaglutide)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in glycosylated haemoglobin (HbA1c)

Percentage point

Secondary Outcome Measures

Change from baseline in fasting plasma glucose (FPG)

mmol/L

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

SDS

Change from baseline in glycosylated haemoglobin (HbA1c)

Percentage point

Change from baseline in FPG

mmol/L

Change from baseline in body weight

Relative change from baseline in body weight

Percentage

Relative change from baseline in body weight

Percentage

Change from baseline in waist circumference

Change from baseline in BMI SDS

SDS

BMI percentile (age and gender adjusted)

Percent

BMI percentile (age and gender adjusted)

Percent

Change from baseline in systolic blood pressure

mmHg

Change from baseline in systolic blood pressure

mmHg

Change from baseline in diastolic blood pressure

mmHg

Change from baseline in diastolic blood pressure

mmHg

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

Count of participants

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

Count of participants

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

Count of participants

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

Count of participants

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

Days

Time to rescue medication (to support the hypothetical estimand)

Days

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

Count of events

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

Count of episodes

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

Count of episodes

Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode

Count of participants

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

Count of participants

Change from baseline in amylase

U/L

Change from baseline in amylase

U/L

Change from baseline in lipase

U/L

Change from baseline in lipase

U/L

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

ng/mL

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

ng/mL

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

ng/mL

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

ng/mL

Change from baseline in calcitonin

pmol/L

Change from baseline in calcitonin

pmol/L

Change from baseline in estradiol (for girls)

pmol/L

Change from baseline in estradiol (for girls)

pmol/L

Change from baseline in testosterone (for boys)

nmol/L

Change from baseline in testosterone (for boys)

nmol/L

Change from baseline in prolactin

mIU/L

Change from baseline in prolactin

mIU/L

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

mIU/L

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

mIU/L

Change from baseline in follicle stimulating hormone (FSH)

mIU/mL

Change from baseline in follicle stimulating hormone (FSH)

mIU/mL

Change from baseline in luteinizing hormone (LH)

mIU/mL

Change from baseline in luteinizing hormone (LH)

mIU/mL

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

μmol/L

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

μmol/L

Anti-semaglutide antibody status

Count of participants

Anti-semaglutide antibody titer

Count of participants

Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide

Count of participants

Anti-semaglutide antibodies cross reacting with endogenous GLP-1

Count of participants

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

Count of participants

Height velocity

cm/year

Height velocity

cm/year

Change from baseline in height SDS

SDS

Change from baseline in bone age assessment, X-ray

Years

Change from baseline in pubertal assessment (Tanner staging)

Stage 1-5 where 5 is full sexual maturity

Change from baseline in pubertal assessment (Tanner staging)

Stage 1-5 where 5 is full sexual maturity

Change from baseline in pulse rate

Beats/minute

Change from baseline in pulse rate

Beats/minute

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

mmol/L

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

mmol/L

Apparent clearance (CL/F)

L/h

Average concentration (Cavg)

nmol/L

SNAC plasma concentrations

ng/mL

Full Information

NCT ID

NCT04596631

First Posted

October 16, 2020

Last Updated

August 21, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04596631

Brief Title

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

Acronym

PIONEER TEENS

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

February 17, 2025 (Anticipated)

Study Completion Date

August 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide - max. tolerated dose

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo (semaglutide)

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Oral semaglutide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

Placebo treatment for 52 weeks.

Primary Outcome Measure Information:

Title

Change from baseline in glycosylated haemoglobin (HbA1c)

Description

Percentage point

Time Frame

Week 0, week 26

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose (FPG)

Description

mmol/L

Time Frame

Week 0, week 26

Title

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

Description

SDS

Time Frame

Week 0, week 26

Title

Change from baseline in glycosylated haemoglobin (HbA1c)

Description

Percentage point

Time Frame

Week 0, week 52

Title

Change from baseline in FPG

Description

mmol/L

Time Frame

Week 0, week 52

Title

Change from baseline in body weight

Description

Time Frame

Week 0, week 26

Title

Change from baseline in body weight

Description

Time Frame

Week 0, week 52

Title

Relative change from baseline in body weight

Description

Percentage

Time Frame

Week 0, week 26

Title

Relative change from baseline in body weight

Description

Percentage

Time Frame

Week 0, week 52

Title

Change from baseline in waist circumference

Description

Time Frame

Week 0, week 26

Title

Change from baseline in waist circumference

Description

Time Frame

Week 0, week 52

Title

Change from baseline in BMI SDS

Description

SDS

Time Frame

Week 0, week 52

Title

BMI percentile (age and gender adjusted)

Description

Percent

Time Frame

Week 0, week 26

Title

BMI percentile (age and gender adjusted)

Description

Percent

Time Frame

Week 0, week 52

Title

Change from baseline in systolic blood pressure

Description

mmHg

Time Frame

Week 0, week 26

Title

Change from baseline in systolic blood pressure

Description

mmHg

Time Frame

Week 0, week 52

Title

Change from baseline in diastolic blood pressure

Description

mmHg

Time Frame

Week 0, week 26

Title

Change from baseline in diastolic blood pressure

Description

mmHg

Time Frame

Week 0, week 52

Title

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

Description

Count of participants

Time Frame

At week 26

Title

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

Description

Count of participants

Time Frame

At week 26

Title

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

Description

Count of participants

Time Frame

At week 52

Title

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

Description

Count of participants

Time Frame

At week 52

Title

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

Description

Days

Time Frame

Week 0 - week 52

Title

Time to rescue medication (to support the hypothetical estimand)

Description

Days

Time Frame

Week 0 - week 52

Title

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

Description

Count of events

Time Frame

Week 0 - week 57

Title

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

Description

Count of episodes

Time Frame

From randomisation (week 0) to week 26

Title

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

Description

Count of episodes

Time Frame

Week 0 - week 57

Title

Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode

Description

Count of participants

Time Frame

From randomisation (week 0) to week 26

Title

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

Description

Count of participants

Time Frame

Week 0 - week 57

Title

Change from baseline in amylase

Description

U/L

Time Frame

Week 0, week 26

Title

Change from baseline in amylase

Description

U/L

Time Frame

Week 0, week 52

Title

Change from baseline in lipase

Description

U/L

Time Frame

Week 0, week 26

Title

Change from baseline in lipase

Description

U/L

Time Frame

Week 0, week 52

Title

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

Description

ng/mL

Time Frame

Week 0, week 26

Title

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

Description

ng/mL

Time Frame

Week 0, week 52

Title

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

Description

ng/mL

Time Frame

Week 0, week 26

Title

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

Description

ng/mL

Time Frame

Week 0, week 52

Title

Change from baseline in calcitonin

Description

pmol/L

Time Frame

Week 0, week 26

Title

Change from baseline in calcitonin

Description

pmol/L

Time Frame

Week 0, week 52

Title

Change from baseline in estradiol (for girls)

Description

pmol/L

Time Frame

Week 0, week 26

Title

Change from baseline in estradiol (for girls)

Description

pmol/L

Time Frame

Week 0, week 52

Title

Change from baseline in testosterone (for boys)

Description

nmol/L

Time Frame

Week 0, week 26

Title

Change from baseline in testosterone (for boys)

Description

nmol/L

Time Frame

Week 0, week 52

Title

Change from baseline in prolactin

Description

mIU/L

Time Frame

Week 0, week 26

Title

Change from baseline in prolactin

Description

mIU/L

Time Frame

Week 0, week 52

Title

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

Description

mIU/L

Time Frame

Week 0, week 26

Title

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

Description

mIU/L

Time Frame

Week 0, week 52

Title

Change from baseline in follicle stimulating hormone (FSH)

Description

mIU/mL

Time Frame

Week 0, week 26

Title

Change from baseline in follicle stimulating hormone (FSH)

Description

mIU/mL

Time Frame

Week 0, week 52

Title

Change from baseline in luteinizing hormone (LH)

Description

mIU/mL

Time Frame

Week 0, week 26

Title

Change from baseline in luteinizing hormone (LH)

Description

mIU/mL

Time Frame

Week 0, week 52

Title

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

Description

μmol/L

Time Frame

Week 0, week 26

Title

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

Description

μmol/L

Time Frame

Week 0, week 52

Title

Anti-semaglutide antibody status

Description

Count of participants

Time Frame

Week 0 - week 57

Title

Anti-semaglutide antibody titer

Description

Count of participants

Time Frame

Up to 57 weeks

Title

Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide

Description

Count of participants

Time Frame

Week 0 to week 57

Title

Anti-semaglutide antibodies cross reacting with endogenous GLP-1

Description

Count of participants

Time Frame

Week 0 to week 57

Title

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

Description

Count of participants

Time Frame

Week 0 to week 57

Title

Height velocity

Description

cm/year

Time Frame

At week 26

Title

Height velocity

Description

cm/year

Time Frame

At week 52

Title

Change from baseline in height SDS

Description

SDS

Time Frame

Week 0, week 26

Title

Change from baseline in bone age assessment, X-ray

Description

Years

Time Frame

Week 0, week 52

Title

Change from baseline in pubertal assessment (Tanner staging)

Description

Stage 1-5 where 5 is full sexual maturity

Time Frame

Week 0, week 26

Title

Change from baseline in pubertal assessment (Tanner staging)

Description

Stage 1-5 where 5 is full sexual maturity

Time Frame

Week 0, week 52

Title

Change from baseline in pulse rate

Description

Beats/minute

Time Frame

Week 0, week 26

Title

Change from baseline in pulse rate

Description

Beats/minute

Time Frame

Week 0, week 52

Title

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

Description

mmol/L

Time Frame

At week 12

Title

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

Description

mmol/L

Time Frame

At week 26

Title

Apparent clearance (CL/F)

Description

L/h

Time Frame

Week 0 - week 52

Title

Average concentration (Cavg)

Description

nmol/L

Time Frame

Week 0 - week 52

Title

SNAC plasma concentrations

Description

ng/mL

Time Frame

Week 0 - week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novo Nordisk

Phone

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808-4124

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Individual Site Status

Suspended

Facility Name

Novo Nordisk Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78233

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Usti nad Labem

ZIP/Postal Code

40113

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11526

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-15125

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Haidari-Athens

ZIP/Postal Code

GR-12462

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Lamia

ZIP/Postal Code

GR35100

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Larissa

ZIP/Postal Code

GR-41110

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Penteli, Athens

ZIP/Postal Code

15236

Country

Greece

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54636

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54643

Country

Greece

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Guntur

State/Province

Andhra Pradesh

ZIP/Postal Code

522001

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kolhapur

State/Province

Maharashtra

ZIP/Postal Code

416008

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

4000016

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

State/Province

New Delhi

ZIP/Postal Code

110029

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302017

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Telangana

ZIP/Postal Code

500072

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700020

Country

India

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700020

Country

India

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Thriruvananthapuram

ZIP/Postal Code

695 032

Country

India

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Hazmieh

ZIP/Postal Code

21211

Country

Lebanon

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Putrajaya

ZIP/Postal Code

62250

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Puebla

ZIP/Postal Code

72190

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Rabat

ZIP/Postal Code

10000

Country

Morocco

Individual Site Status

Not yet recruiting

Facility Name

Novo Nordisk Investigational Site

City

Almere

ZIP/Postal Code

1315 RC

Country

Netherlands

Individual Site Status

Suspended

Facility Name

Novo Nordisk Investigational Site

City

Den Bosch

ZIP/Postal Code

5223GZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Grafton

ZIP/Postal Code

1023

Country

New Zealand

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Lisboa

ZIP/Postal Code

1500-650

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Individual Site Status

Active, not recruiting

Facility Name

Novo Nordisk Investigational Site

City

Vila Nova de Gaia

ZIP/Postal Code

4400-129

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Targoviste

State/Province

Dambovita

ZIP/Postal Code

130086

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Brasov

ZIP/Postal Code

500260

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Bucharest

ZIP/Postal Code

041451

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Izhevsk

ZIP/Postal Code

426009

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125373

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630048

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Omsk

ZIP/Postal Code

644001

Country

Russian Federation

Individual Site Status

Completed

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191144

Country

Russian Federation

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Individual Site Status

Completed

Facility Name

Novo Nordisk Investigational Site

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Dnipro

ZIP/Postal Code

49023

Country

Ukraine

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kharkiv

ZIP/Postal Code

61000

Country

Ukraine

Individual Site Status

Recruiting

Facility Name

Novo Nordisk Investigational Site

City

Kiev

ZIP/Postal Code

01021

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

03039

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Vinnytsia

ZIP/Postal Code

21010

Country

Ukraine

Individual Site Status

Withdrawn

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B4 6NH

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

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

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

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial