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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04596631
Collaborator
(none)
132
Enrollment
64
Locations
2
Arms
51.5
Anticipated Duration (Months)
2.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Oral semaglutide
  • Drug: Placebo (semaglutide)
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 2, 2020
Anticipated Primary Completion Date :
May 19, 2024
Anticipated Study Completion Date :
Feb 17, 2025

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Change from baseline in glycosylated haemoglobin (HbA1c) [Week 0, week 26]

    Percentage point

Secondary Outcome Measures

  1. Change from baseline in fasting plasma glucose (FPG) [Week 0, week 26]

    mmol/L

  2. Change from baseline in body mass index (BMI) standard deviation score (SDS) [Week 0, week 26]

    SDS

  3. Change from baseline in glycosylated haemoglobin (HbA1c) [Week 0, week 52]

    Percentage point

  4. Change from baseline in FPG [Week 0, week 52]

    mmol/L

  5. Change from baseline in body weight [Week 0, week 26]

    kg

  6. Change from baseline in body weight [Week 0, week 52]

    kg

  7. Relative change from baseline in body weight [Week 0, week 26]

    Percentage

  8. Relative change from baseline in body weight [Week 0, week 52]

    Percentage

  9. Change from baseline in waist circumference [Week 0, week 26]

    cm

  10. Change from baseline in waist circumference [Week 0, week 52]

    cm

  11. Change from baseline in BMI SDS [Week 0, week 52]

    SDS

  12. BMI percentile (age and gender adjusted) [Week 0, week 26]

    Percent

  13. BMI percentile (age and gender adjusted) [Week 0, week 52]

    Percent

  14. Change from baseline in systolic blood pressure [Week 0, week 26]

    mmHg

  15. Change from baseline in systolic blood pressure [Week 0, week 52]

    mmHg

  16. Change from baseline in diastolic blood pressure [Week 0, week 26]

    mmHg

  17. Change from baseline in diastolic blood pressure [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 [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 [At week 26]

    Count of participants

  20. HbA1c below 7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018 [At week 52]

    Count of participants

  21. HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), AACE targetat week 26 [At week 52]

    Count of participants

  22. Time to additional anti-diabetic medication (to support the treatment policy estimand) [Week 0 - week 52]

    Days

  23. Time to rescue medication (to support the hypothetical estimand) [Week 0 - week 52]

    Days

  24. Number of treatment-emergent adverse events (TEAEs) during exposure to trial product [Week 0 - week 57]

    Count of events

  25. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [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 [Week 0 - week 57]

    Count of episodes

  27. Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode [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 [Week 0 - week 57]

    Count of participants

  29. Change from baseline in amylase [Week 0, week 26]

    U/L

  30. Change from baseline in amylase [Week 0, week 52]

    U/L

  31. Change from baseline in lipase [Week 0, week 26]

    U/L

  32. Change from baseline in lipase [Week 0, week 52]

    U/L

  33. Change from baseline in insulin-like growth factor 1 (IGF-1) [Week 0, week 26]

    ng/mL

  34. Change from baseline in insulin-like growth factor 1 (IGF-1) [Week 0, week 52]

    ng/mL

  35. Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3) [Week 0, week 26]

    ng/mL

  36. Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3) [Week 0, week 52]

    ng/mL

  37. Change from baseline in calcitonin [Week 0, week 26]

    pmol/L

  38. Change from baseline in calcitonin [Week 0, week 52]

    pmol/L

  39. Change from baseline in estradiol (for girls) [Week 0, week 26]

    pmol/L

  40. Change from baseline in estradiol (for girls) [Week 0, week 52]

    pmol/L

  41. Change from baseline in testosterone (for boys) [Week 0, week 26]

    nmol/L

  42. Change from baseline in testosterone (for boys) [Week 0, week 52]

    nmol/L

  43. Change from baseline in prolactin [Week 0, week 26]

    mIU/L

  44. Change from baseline in prolactin [Week 0, week 52]

    mIU/L

  45. Change from baseline in thyroid stimulating hormone (TSH/thyrotropin) [Week 0, week 26]

    mIU/L

  46. Change from baseline in thyroid stimulating hormone (TSH/thyrotropin) [Week 0, week 52]

    mIU/L

  47. Change from baseline in follicle stimulating hormone (FSH) [Week 0, week 26]

    mIU/mL

  48. Change from baseline in follicle stimulating hormone (FSH) [Week 0, week 52]

    mIU/mL

  49. Change from baseline in luteinizing hormone (LH) [Week 0, week 26]

    mIU/mL

  50. Change from baseline in luteinizing hormone (LH) [Week 0, week 52]

    mIU/mL

  51. Change from baseline in dehydroepiandrosterone sulfate (DHEAS) [Week 0, week 26]

    μmol/L

  52. Change from baseline in dehydroepiandrosterone sulfate (DHEAS) [Week 0, week 52]

    μmol/L

  53. Anti-semaglutide antibodies [Week 0 - week 57]

    Count of participants

  54. Anti-semaglutide antibodies with in vitro neutralising effect [Week 0 to week 57]

    Count of participants

  55. Anti-semaglutide antibodies cross reacting with endogenous GLP-1 [Week 0 to week 57]

    Count of participants

  56. Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 [Week 0 to week 57]

    Count of participants

  57. Anti-semaglutide antibody level [Week 0 to week 57]

    Percent bound/total

  58. Height velocity [At week 26]

    cm/year

  59. Height velocity [At week 52]

    cm/year

  60. Change from baseline in height SDS [Week 0, week 26]

    SDS

  61. Change from baseline in bone age assessment, X-ray [Week 0, week 52]

    Years

  62. Change from baseline in pubertal assessment (Tanner staging) [Week 0, week 26]

    Stage 1-5 where 5 is full sexual maturity

  63. Change from baseline in pubertal assessment (Tanner staging) [Week 0, week 52]

    Stage 1-5 where 5 is full sexual maturity

  64. Change from baseline in pulse rate [Week 0, week 26]

    Beats/minute

  65. Change from baseline in pulse rate [Week 0, week 52]

    Beats/minute

  66. Change from pre-dose to post-dose (25 and 40 min) in lactate [At week 12]

    mmol/L

  67. Change from pre-dose to post-dose (25 and 40 min) in lactate [At week 26]

    mmol/L

  68. Apparent clearance (CL/F) [Week 0 - week 52]

    L/h

  69. Average concentration (Cavg) [Week 0 - week 52]

    nmol/L

  70. SNAC plasma concentrations [Week 0 - week 52]

    ng/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteBirminghamAlabamaUnited States35233
2Novo Nordisk Investigational SiteLos AngelesCaliforniaUnited States90027
3Novo Nordisk Investigational SiteNew HavenConnecticutUnited States06520
4Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32207
5Novo Nordisk Investigational SiteTampaFloridaUnited States33612
6Novo Nordisk Investigational SiteColumbusGeorgiaUnited States31904
7Novo Nordisk Investigational SiteIndianapolisIndianaUnited States46202
8Novo Nordisk Investigational SiteLouisvilleKentuckyUnited States40202
9Novo Nordisk Investigational SiteBaton RougeLouisianaUnited States70808-4124
10Novo Nordisk Investigational SiteJacksonMississippiUnited States39216
11Novo Nordisk Investigational SiteBuffaloNew YorkUnited States14203
12Novo Nordisk Investigational SitePittsburghPennsylvaniaUnited States15224
13Novo Nordisk Investigational SiteRapid CitySouth DakotaUnited States57701
14Novo Nordisk Investigational SiteNashvilleTennesseeUnited States37232
15Novo Nordisk Investigational SiteAmarilloTexasUnited States79106
16Novo Nordisk Investigational SiteLive OakTexasUnited States78233
17Novo Nordisk Investigational SiteRichmondVirginiaUnited States23298
18Novo Nordisk Investigational SiteWestmeadNew South WalesAustralia2145
19Novo Nordisk Investigational SiteSalzburgAustria5020
20Novo Nordisk Investigational SiteBrusselBelgium1090
21Novo Nordisk Investigational SiteBruxellesBelgium1200
22Novo Nordisk Investigational SiteNamurBelgium5000
23Novo Nordisk Investigational SiteOstrava-PorubaCzechia708 52
24Novo Nordisk Investigational SiteUsti nad LabemCzechia40113
25Novo Nordisk Investigational SiteAthensGreeceGR-11526
26Novo Nordisk Investigational SiteAthensGreeceGR-15125
27Novo Nordisk Investigational SiteAthensGreeceGR-15125
28Novo Nordisk Investigational SiteHaidari-AthensGreeceGR-12462
29Novo Nordisk Investigational SiteIoanninaGreece45500
30Novo Nordisk Investigational SiteLamiaGreeceGR35100
31Novo Nordisk Investigational SiteLarissaGreeceGR-41110
32Novo Nordisk Investigational SitePenteli, AthensGreece15236
33Novo Nordisk Investigational SiteThessalonikiGreeceGR-54636
34Novo Nordisk Investigational SiteThessalonikiGreeceGR-54643
35Novo Nordisk Investigational SiteGunturAndhra PradeshIndia522001
36Novo Nordisk Investigational SiteHyderabadAndhra PradeshIndia500072
37Novo Nordisk Investigational SiteMumbaiMaharashtraIndia4000016
38Novo Nordisk Investigational SiteNew DehliNew DelhiIndia110029
39Novo Nordisk Investigational SiteJaipurRajasthanIndia302017
40Novo Nordisk Investigational SiteKolhapurIndia416008
41Novo Nordisk Investigational SiteThriruvananthapuramIndia695 032
42Novo Nordisk Investigational SiteBeer ShevaIsrael84101
43Novo Nordisk Investigational SiteHaifaIsrael31096
44Novo Nordisk Investigational SiteHazmiehLebanon9615
45Novo Nordisk Investigational SiteKuala LumpurMalaysia59100
46Novo Nordisk Investigational SitePutrajayaMalaysia62250
47Novo Nordisk Investigational SitePueblaMexico72190
48Novo Nordisk Investigational SiteRabatMorocco10000
49Novo Nordisk Investigational SiteAlmereNetherlands1315 RC
50Novo Nordisk Investigational SiteDen BoschNetherlands5223GZ
51Novo Nordisk Investigational SiteGraftonNew Zealand1023
52Novo Nordisk Investigational SiteSkopjeNorth Macedonia1000
53Novo Nordisk Investigational SiteLisboaPortugal1649-035
54Novo Nordisk Investigational SiteVila Nova de GaiaPortugal4400-129
55Novo Nordisk Investigational SitePoncePuerto Rico00716
56Novo Nordisk Investigational SiteMoscowRussian Federation125373
57Novo Nordisk Investigational SiteNovosibirskRussian Federation630048
58Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation191144
59Novo Nordisk Investigational SiteTomskRussian Federation634050
60Novo Nordisk Investigational SiteTaipeiTaiwan104
61Novo Nordisk Investigational SiteTaoyuanTaiwan333
62Novo Nordisk Investigational SiteDniproUkraine49023
63Novo Nordisk Investigational SiteKharkivUkraine61000
64Novo Nordisk Investigational SiteKyivUkraine04114

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04596631
Other Study ID Numbers:
  • NN9924-4437
  • U1111-1218-1527
  • 2018-002952-34
First Posted:
Oct 22, 2020
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2021