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)
• Enrollment: 132
• Locations: 71
• Arms: 2
• Anticipated Duration (Months): 51.5
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0

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 Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	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

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

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

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Birmingham	Alabama	United States	35233
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90027
3	Novo Nordisk Investigational Site	New Haven	Connecticut	United States	06520
4	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32207
5	Novo Nordisk Investigational Site	Tampa	Florida	United States	33612
6	Novo Nordisk Investigational Site	Columbus	Georgia	United States	31904
7	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46202
8	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40202
9	Novo Nordisk Investigational Site	Baton Rouge	Louisiana	United States	70808-4124
10	Novo Nordisk Investigational Site	Baltimore	Maryland	United States	21229
11	Novo Nordisk Investigational Site	Jackson	Mississippi	United States	39216
12	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
13	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
14	Novo Nordisk Investigational Site	Rapid City	South Dakota	United States	57701
15	Novo Nordisk Investigational Site	Nashville	Tennessee	United States	37232
16	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
17	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78207
18	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78233
19	Novo Nordisk Investigational Site	Richmond	Virginia	United States	23298
20	Novo Nordisk Investigational Site	Westmead	New South Wales	Australia	2145
21	Novo Nordisk Investigational Site	Salzburg		Austria	5020
22	Novo Nordisk Investigational Site	Brussel		Belgium	1090
23	Novo Nordisk Investigational Site	Bruxelles		Belgium	1200
24	Novo Nordisk Investigational Site	Namur		Belgium	5000
25	Novo Nordisk Investigational Site	Ostrava-Poruba		Czechia	708 52
26	Novo Nordisk Investigational Site	Usti nad Labem		Czechia	40113
27	Novo Nordisk Investigational Site	Athens		Greece	GR-11526
28	Novo Nordisk Investigational Site	Athens		Greece	GR-15125
29	Novo Nordisk Investigational Site	Athens		Greece	GR-15125
30	Novo Nordisk Investigational Site	Haidari-Athens		Greece	GR-12462
31	Novo Nordisk Investigational Site	Ioannina		Greece	45500
32	Novo Nordisk Investigational Site	Lamia		Greece	GR35100
33	Novo Nordisk Investigational Site	Larissa		Greece	GR-41110
34	Novo Nordisk Investigational Site	Penteli, Athens		Greece	15236
35	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54636
36	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54643
37	Novo Nordisk Investigational Site	Guntur	Andhra Pradesh	India	522001
38	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500072
39	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	4000016
40	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
41	Novo Nordisk Investigational Site	Jaipur	Rajasthan	India	302017
42	Novo Nordisk Investigational Site	Kolkata	West Bengal	India	700020
43	Novo Nordisk Investigational Site	Kolhapur		India	416008
44	Novo Nordisk Investigational Site	Thriruvananthapuram		India	695 032
45	Novo Nordisk Investigational Site	Beer Sheva		Israel	84101
46	Novo Nordisk Investigational Site	Haifa		Israel	31096
47	Novo Nordisk Investigational Site	Hazmieh		Lebanon	21211
48	Novo Nordisk Investigational Site	Kuala Lumpur		Malaysia	59100
49	Novo Nordisk Investigational Site	Putrajaya		Malaysia	62250
50	Novo Nordisk Investigational Site	Puebla		Mexico	72190
51	Novo Nordisk Investigational Site	Rabat		Morocco	10000
52	Novo Nordisk Investigational Site	Almere		Netherlands	1315 RC
53	Novo Nordisk Investigational Site	Den Bosch		Netherlands	5223GZ
54	Novo Nordisk Investigational Site	Grafton		New Zealand	1023
55	Novo Nordisk Investigational Site	Skopje		North Macedonia	1000
56	Novo Nordisk Investigational Site	Lisboa		Portugal	1500-650
57	Novo Nordisk Investigational Site	Lisboa		Portugal	1649-035
58	Novo Nordisk Investigational Site	Vila Nova de Gaia		Portugal	4400-129
59	Novo Nordisk Investigational Site	Ponce		Puerto Rico	00716
60	Novo Nordisk Investigational Site	Izhevsk		Russian Federation	426009
61	Novo Nordisk Investigational Site	Moscow		Russian Federation	125373
62	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630048
63	Novo Nordisk Investigational Site	Omsk		Russian Federation	644001
64	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	191144
65	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
66	Novo Nordisk Investigational Site	Taipei		Taiwan	104
67	Novo Nordisk Investigational Site	Taoyuan		Taiwan	333
68	Novo Nordisk Investigational Site	Dnipro		Ukraine	49023
69	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61000
70	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
71	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B4 6NH

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: Mar 21, 2022
• Last Verified: Mar 1, 2022

• 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: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 21, 2022