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Completed

NCT Number: NCT04596631

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gosford Hospital, Gosford, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral semaglutide

Drug

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

Placebo (semaglutide)

Drug

Placebo treatment for 52 weeks.

Primary outcomes

  1. Change from baseline in glycosylated haemoglobin (HbA1c)

    Time frame: Week 0, week 26

    Percentage point

Secondary outcomes

  1. Change from baseline in fasting plasma glucose (FPG)

    Time frame: Week 0, week 26

    mmol/L

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

    Time frame: Week 0, week 26

    SDS

  3. Change from baseline in glycosylated haemoglobin (HbA1c)

    Time frame: Week 0, week 52

    Percentage point

  4. Change from baseline in FPG

    Time frame: Week 0, week 52

    mmol/L

  5. Change from baseline in body weight

    Time frame: Week 0, week 26

    kg

  6. Change from baseline in body weight

    Time frame: Week 0, week 52

    kg

  7. Relative change from baseline in body weight

    Time frame: Week 0, week 26

    Percentage

  8. Relative change from baseline in body weight

    Time frame: Week 0, week 52

    Percentage

  9. Change from baseline in waist circumference

    Time frame: Week 0, week 26

    cm

  10. Change from baseline in waist circumference

    Time frame: Week 0, week 52

    cm

  11. Change from baseline in BMI SDS

    Time frame: Week 0, week 52

    SDS

  12. BMI percentile (age and gender adjusted)

    Time frame: Week 0, week 26

    Percent

  13. BMI percentile (age and gender adjusted)

    Time frame: Week 0, week 52

    Percent

  14. Change from baseline in systolic blood pressure

    Time frame: Week 0, week 26

    mmHg

  15. Change from baseline in systolic blood pressure

    Time frame: Week 0, week 52

    mmHg

  16. Change from baseline in diastolic blood pressure

    Time frame: Week 0, week 26

    mmHg

  17. Change from baseline in diastolic blood pressure

    Time frame: Week 0, week 52

    mmHg

  18. 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

    Count of participants

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

    Time frame: At week 26

    Count of participants

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

    Time frame: At week 52

    Count of participants

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

    Time frame: At week 52

    Count of participants

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

    Time frame: Week 0 - week 52

    Days

  23. Time to rescue medication (to support the hypothetical estimand)

    Time frame: Week 0 - week 52

    Days

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

    Time frame: Week 0 - week 57

    Count of events

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

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

    Count of episodes

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

    Time frame: Week 0 - week 57

    Count of episodes

  27. Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode

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

    Count of participants

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

    Time frame: Week 0 - week 57

    Count of participants

  29. Change from baseline in amylase

    Time frame: Week 0, week 26

    U/L

  30. Change from baseline in amylase

    Time frame: Week 0, week 52

    U/L

  31. Change from baseline in lipase

    Time frame: Week 0, week 26

    U/L

  32. Change from baseline in lipase

    Time frame: Week 0, week 52

    U/L

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

    Time frame: Week 0, week 26

    ng/mL

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

    Time frame: Week 0, week 52

    ng/mL

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

    Time frame: Week 0, week 26

    ng/mL

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

    Time frame: Week 0, week 52

    ng/mL

  37. Change from baseline in calcitonin

    Time frame: Week 0, week 26

    pmol/L

  38. Change from baseline in calcitonin

    Time frame: Week 0, week 52

    pmol/L

  39. Change from baseline in estradiol (for girls)

    Time frame: Week 0, week 26

    pmol/L

  40. Change from baseline in estradiol (for girls)

    Time frame: Week 0, week 52

    pmol/L

  41. Change from baseline in testosterone (for boys)

    Time frame: Week 0, week 26

    nmol/L

  42. Change from baseline in testosterone (for boys)

    Time frame: Week 0, week 52

    nmol/L

  43. Change from baseline in prolactin

    Time frame: Week 0, week 26

    mIU/L

  44. Change from baseline in prolactin

    Time frame: Week 0, week 52

    mIU/L

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

    Time frame: Week 0, week 26

    mIU/L

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

    Time frame: Week 0, week 52

    mIU/L

  47. Change from baseline in follicle stimulating hormone (FSH)

    Time frame: Week 0, week 26

    mIU/mL

  48. Change from baseline in follicle stimulating hormone (FSH)

    Time frame: Week 0, week 52

    mIU/mL

  49. Change from baseline in luteinizing hormone (LH)

    Time frame: Week 0, week 26

    mIU/mL

  50. Change from baseline in luteinizing hormone (LH)

    Time frame: Week 0, week 52

    mIU/mL

  51. Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

    Time frame: Week 0, week 26

    μmol/L

  52. Change from baseline in dehydroepiandrosterone sulfate (DHEAS)

    Time frame: Week 0, week 52

    μmol/L

  53. Anti-semaglutide antibody status

    Time frame: Week 0 - week 57

    Count of participants

  54. Anti-semaglutide antibody titer

    Time frame: Up to 57 weeks

    Count of participants

  55. Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide

    Time frame: Week 0 to week 57

    Count of participants

  56. Anti-semaglutide antibodies cross reacting with endogenous GLP-1

    Time frame: Week 0 to week 57

    Count of participants

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

    Time frame: Week 0 to week 57

    Count of participants

  58. Height velocity

    Time frame: At week 26

    cm/year

  59. Height velocity

    Time frame: At week 52

    cm/year

  60. Change from baseline in height SDS

    Time frame: Week 0, week 26

    SDS

  61. Change from baseline in bone age assessment, X-ray

    Time frame: Week 0, week 52

    Years

  62. Change from baseline in pubertal assessment (Tanner staging)

    Time frame: Week 0, week 26

    Stage 1-5 where 5 is full sexual maturity

  63. Change from baseline in pubertal assessment (Tanner staging)

    Time frame: Week 0, week 52

    Stage 1-5 where 5 is full sexual maturity

  64. Change from baseline in pulse rate

    Time frame: Week 0, week 26

    Beats/minute

  65. Change from baseline in pulse rate

    Time frame: Week 0, week 52

    Beats/minute

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

    Time frame: At week 12

    mmol/L

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

    Time frame: At week 26

    mmol/L

  68. Apparent clearance (CL/F)

    Time frame: Week 0 - week 52

    L/h

  69. Average concentration (Cavg)

    Time frame: Week 0 - week 52

    nmol/L

  70. SNAC plasma concentrations

    Time frame: Week 0 - week 52

    ng/mL

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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