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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)

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ClinicalTrials.gov Identifier: NCT04596631
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Oral semaglutide Drug: Placebo (semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : May 19, 2024
Estimated Study Completion Date : February 17, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide - max. tolerated dose
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
Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Placebo Comparator: Placebo (semaglutide)
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)
Placebo treatment for 52 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]
    Percentage point


Secondary Outcome Measures :
  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 antibodies [ Time Frame: Week 0 - week 57 ]
    Count of participants

  54. Anti-semaglutide antibodies with in vitro neutralising effect [ Time Frame: Week 0 to week 57 ]
    Count of participants

  55. Anti-semaglutide antibodies cross reacting with endogenous GLP-1 [ Time Frame: Week 0 to week 57 ]
    Count of participants

  56. Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 [ Time Frame: Week 0 to week 57 ]
    Count of participants

  57. Anti-semaglutide antibody level [ Time Frame: Week 0 to week 57 ]
    Percent bound/total

  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/L


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596631


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04596631    
Other Study ID Numbers: NN9924-4437
U1111-1218-1527 ( Other Identifier: World Health Organization (WHO) )
2018-002952-34 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases