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

Novo Nordisk A/S132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (97)

UAB Ped Endo Children's Hosp

Birmingham, Alabama, United States

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Yale School Of Medicine

New Haven, Connecticut, United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Nemours Children's Health

Pensacola, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in glycosylated haemoglobin (HbA1c)

Percentage point

Time frame: Week 0, week 26

Secondary Outcomes

Change from baseline in fasting plasma glucose (FPG)

mmol/L

Time frame: Week 0, week 26

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

SDS

Time frame: Week 0, week 26

Change from baseline in glycosylated haemoglobin (HbA1c)

Percentage point

Time frame: Week 0, week 52

Change from baseline in FPG

mmol/L

Time frame: Week 0, week 52

Change from baseline in body weight

Time frame: Week 0, week 26

Change from baseline in body weight

Time frame: Week 0, week 52

Relative change from baseline in body weight

Percentage

Time frame: Week 0, week 26

Relative change from baseline in body weight

Percentage

Time frame: Week 0, week 52

Change from baseline in waist circumference

Time frame: Week 0, week 26

Change from baseline in waist circumference

Time frame: Week 0, week 52

Change from baseline in BMI SDS

SDS

Time frame: Week 0, week 52

BMI percentile (age and gender adjusted)

Percent

Time frame: Week 0, week 26

BMI percentile (age and gender adjusted)

Percent

Time frame: Week 0, week 52

Change from baseline in systolic blood pressure

mmHg

Time frame: Week 0, week 26

Change from baseline in systolic blood pressure

mmHg

Time frame: Week 0, week 52

Change from baseline in diastolic blood pressure

mmHg

Time frame: Week 0, week 26

Change from baseline in diastolic blood pressure

mmHg

Time frame: Week 0, week 52

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

Time frame: At week 26

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

Count of participants

Time frame: At week 26

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

Count of participants

Time frame: At week 52

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

Count of participants

Time frame: At week 52

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

Days

Time frame: Week 0 - week 52

Time to rescue medication (to support the hypothetical estimand)

Days

Time frame: Week 0 - week 52

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

Count of events

Time frame: Week 0 - week 57

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

Count of episodes

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

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

Count of episodes

Time frame: Week 0 - week 57

Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode

Count of participants

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

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

Count of participants

Time frame: Week 0 - week 57

Change from baseline in amylase

U/L

Time frame: Week 0, week 26

Change from baseline in amylase

U/L

Time frame: Week 0, week 52

Change from baseline in lipase

U/L

Time frame: Week 0, week 26

Change from baseline in lipase

U/L

Time frame: Week 0, week 52

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

ng/mL

Time frame: Week 0, week 26

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

ng/mL

Time frame: Week 0, week 52

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

ng/mL

Time frame: Week 0, week 26

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

ng/mL

Time frame: Week 0, week 52

Change from baseline in calcitonin

pmol/L

Time frame: Week 0, week 26

Change from baseline in calcitonin

pmol/L

Time frame: Week 0, week 52

Change from baseline in estradiol (for girls)

pmol/L

Time frame: Week 0, week 26

Change from baseline in estradiol (for girls)

pmol/L

Time frame: Week 0, week 52

Change from baseline in testosterone (for boys)

nmol/L

Time frame: Week 0, week 26

Change from baseline in testosterone (for boys)

nmol/L

Time frame: Week 0, week 52

Change from baseline in prolactin

mIU/L

Time frame: Week 0, week 26

Change from baseline in prolactin

mIU/L

Time frame: Week 0, week 52

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

mIU/L

Time frame: Week 0, week 26

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

mIU/L

Time frame: Week 0, week 52

Change from baseline in follicle stimulating hormone (FSH)

mIU/mL

Time frame: Week 0, week 26

Change from baseline in follicle stimulating hormone (FSH)

mIU/mL

Time frame: Week 0, week 52

Change from baseline in luteinizing hormone (LH)

mIU/mL

Time frame: Week 0, week 26

Change from baseline in luteinizing hormone (LH)

mIU/mL

Time frame: Week 0, week 52

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

μmol/L

Time frame: Week 0, week 26

Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

μmol/L

Time frame: Week 0, week 52

Anti-semaglutide antibody status

Count of participants

Time frame: Week 0 - week 57

Anti-semaglutide antibody titer

Count of participants

Time frame: Up to 57 weeks

Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide

Count of participants

Time frame: Week 0 to week 57

Anti-semaglutide antibodies cross reacting with endogenous GLP-1

Count of participants

Time frame: Week 0 to week 57

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

Count of participants

Time frame: Week 0 to week 57

Height velocity

cm/year

Time frame: At week 26

Height velocity

cm/year

Time frame: At week 52

Change from baseline in height SDS

SDS

Time frame: Week 0, week 26

Change from baseline in bone age assessment, X-ray

Years

Time frame: Week 0, week 52

Change from baseline in pubertal assessment (Tanner staging)

Stage 1-5 where 5 is full sexual maturity

Time frame: Week 0, week 26

Change from baseline in pubertal assessment (Tanner staging)

Stage 1-5 where 5 is full sexual maturity

Time frame: Week 0, week 52

Change from baseline in pulse rate

Beats/minute

Time frame: Week 0, week 26

Change from baseline in pulse rate

Beats/minute

Time frame: Week 0, week 52

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

mmol/L

Time frame: At week 12

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

mmol/L

Time frame: At week 26

Apparent clearance (CL/F)

L/h

Time frame: Week 0 - week 52

Average concentration (Cavg)

nmol/L

Time frame: Week 0 - week 52

SNAC plasma concentrations

ng/mL

Time frame: Week 0 - week 52