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Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (REAL 1)

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ClinicalTrials.gov Identifier: NCT02229851
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : July 7, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somapacitan Drug: somatropin Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
Actual Study Start Date : October 31, 2014
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : May 7, 2018


Arm Intervention/treatment
Experimental: NNC0195-0092 (somapacitan) Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
Other Name: NNC0195-0092

Active Comparator: Daily hGH Drug: somatropin
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.

Placebo Comparator: Placebo
Switch to NNC0195-0092 (somapacitan) treatment in the extension period.
Drug: somapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
Other Name: NNC0195-0092

Drug: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.




Primary Outcome Measures :
  1. Change in Truncal Fat Percentage (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).


Secondary Outcome Measures :
  1. Change in Truncal Fat Percentage (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  2. Change in Truncal Fat Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  3. Change in Truncal Fat Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  4. Change in Truncal Lean Body Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  5. Change in Truncal Lean Body Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  6. Change in Total Fat Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  7. Change in Total Fat Mass (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  8. Change in Visceral Adipose Tissue (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

  9. Change in Visceral Adipose Tissue (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  10. Change in Android Fat Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  11. Change in Android Fat Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  12. Change in Gynoid Fat Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  13. Change in Gynoid Fat Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  14. Change in Appendicular Skeletal Muscle Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  15. Change in Appendicular Skeletal Muscle Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  16. Change in Lean Body Mass (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

  17. Change in Lean Body Mass (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  18. Change in Bone Mineral Content (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  19. Change in Bone Mineral Density (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  20. Change in IGF-I SDS (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.

  21. Change in IGF-I SDS (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.

  22. Change in IGFBP 3 SDS (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).

  23. Change in IGFBP 3 SDS (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  24. Change in TRIM-AGHD (Total and Domain Scores) (Week 34) [ Time Frame: Week 0, week 34 ]
    Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

  25. Change in TRIM-AGHD (Total and Domain Scores) (Week 87) [ Time Frame: week 0, week 87 ]
    Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.

  26. Change in SF-36v2 (Summary and Domain Scores) (Week 34) [ Time Frame: Week 0, week 34 ]
    SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

  27. Change in SF-36v2 (Summary and Domain Scores) (Week 87) [ Time Frame: week 0, week 87 ]
    SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.

  28. TSQM-9 Scores (Domain Scores) (Week 34) [ Time Frame: Week 34 ]
    Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

  29. TSQM-9 Scores (Domain Scores) (Week 87) [ Time Frame: Week 87 ]
    Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.

  30. Change in Total Cholesterol (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

  31. Change in Total Cholesterol (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  32. Change in HDL-cholesterol (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

  33. Change in HDL-cholesterol (Week 87) [ Time Frame: week -3, week 87 ]
    Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  34. Change in LDL-cholesterol (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).

  35. Change in LDL-cholesterol (Week 87) [ Time Frame: week -3, week 87 ]
    Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  36. Change in Triglycerides (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).

  37. Change in Triglycerides (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  38. Change in Hs-CRP (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  39. Change in Hs-CRP (Week 87) [ Time Frame: week -3, week 87 ]
    Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  40. Change in IL-6 (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  41. Change in IL-6 (Week 87) [ Time Frame: week -3, week 87 ]
    Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  42. Change in Body Weight (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).

  43. Change in Body Weight (Week 87) [ Time Frame: week -3, week 87 ]
    Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  44. Change in Waist Circumference (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).

  45. Change in Waist Circumference (Week 87) [ Time Frame: week -3, week 87 ]
    Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  46. Number of Adverse Events (Weeks 0-35) [ Time Frame: Weeks 0-35 ]
    Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.

  47. Number of Adverse Events (Weeks 0-88) [ Time Frame: Weeks 0-88 ]
    Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.

  48. Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) [ Time Frame: Weeks 0 to 35 ]
    Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

  49. Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) [ Time Frame: Weeks 0 to 88 ]
    Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.

  50. Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) [ Time Frame: Weeks 0 to 35 ]
    Incidence of technical complaints were recorded from baseline (week 0) until week 35.

  51. Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) [ Time Frame: Weeks 0 to 88 ]
    Incidence of technical complaints were recorded from baseline (week 0) until week 88.

  52. Change in Physical Examination During Exposure to Trial Product (Week 35) [ Time Frame: Week 0 and week 35 ]
    Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

  53. Change in Physical Examination During Exposure to Trial Product (Week 88) [ Time Frame: Week 0 and week 88 ]
    Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation

  54. Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) [ Time Frame: Week -3 and week 35 ]
    Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.

  55. Change in ECG Evaluation During Exposure to Trial Product (Week 88) [ Time Frame: Week -3 and week 88 ]
    Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.

  56. Change in Diastolic Blood Pressure (Week 35) [ Time Frame: Week -3, week 35 ]
    Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

  57. Change in Diastolic Blood Pressure (Week 88) [ Time Frame: Week -3, week 88 ]
    Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.

  58. Change in Systolic Blood Pressure (Week 35) [ Time Frame: Week -3, week 35 ]
    Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).

  59. Change in Systolic Blood Pressure (Week 88) [ Time Frame: Week -3, week 88 ]
    Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).

  60. Change in Pulse (Week 35) [ Time Frame: Week -3, week 35 ]
    Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).

  61. Change in Pulse (Week 88) [ Time Frame: Week -3, week 88 ]
    Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).

  62. Change in Haemoglobin (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).

  63. Change in Haemoglobin (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.

  64. Change in Haematocrit (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).

  65. Change in Haematocrit (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.

  66. Change in Erythrocytes (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

  67. Change in Erythrocytes (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.

  68. Change in Mean Corpuscular Volume (MCV) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  69. Change in Mean Corpuscular Volume (MCV) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.

  70. Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  71. Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.

  72. Change in Thrombocytes (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

  73. Change in Thrombocytes (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.

  74. Change in Leucocytes (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).

  75. Change in Leucocytes (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.

  76. Change in Alanine Aminotransferase (ALT) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).

  77. Change in Alanine Aminotransferase (ALT) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in ALT was measured from baseline (week -3) until the end of the week 87.

  78. Change in Albumin (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).

  79. Change in Albumin (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Albumin was measured from baseline (week -3) until the end of the week 87.

  80. Change in Alkaline Phosphatase (ALP) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  81. Change in Alkaline Phosphatase (AP) (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.

  82. Change in Aspartate Aminotransferase (AST) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).

  83. Change in Aspartate Aminotransferase (AST) (Week 87) [ Time Frame: Week -3, week 87 ]
    Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  84. Change in Bilirubin (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).

  85. Change in Bilirubin (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  86. Change in Calcium (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).

  87. Change in Calcium (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Calcium was measured from baseline (week -3) until the end of the week 87.

  88. Change in Chloride (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).

  89. Change in Chloride (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Chloride was measured from baseline (week -3) until the end of the week 87.

  90. Change in Creatinine (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).

  91. Change in Creatinine (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Creatinine was measured from baseline (week -3) until the end of the week 87.

  92. Change in Creatine Kinase (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).

  93. Change in Creatine Kinase (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.

  94. Change in Gamma-glutamyl Transferase (GGT) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).

  95. Change in Gamma-glutamyl Transferase (GGT) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in GGT was measured from baseline (week -3) until the end of the week 87.

  96. Change in Phosphate (Inorganic) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  97. Change in Phosphate (Inorganic)(Week 87) [ Time Frame: week -3, week 87 ]
    Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.

  98. Change in Potassium (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).

  99. Change in Potassium (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Potassium was measured from baseline (week -3) until the end of the week 87.

  100. Change in Sodium (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).

  101. Change in Sodium (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  102. Change in Total Protein (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).

  103. Change in Total Protein (Week 87) [ Time Frame: week -3, week 87 ]
    Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).

  104. Change in Urea (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).

  105. Change in Urea (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  106. Change in Uric Acid (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).

  107. Change in Uric Acid (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  108. Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  109. Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  110. Change in Fasting Plasma Glucose (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).

  111. Change in Fasting Plasma Glucose (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  112. Change in Fasting Insulin (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).

  113. Change in Fasting Insulin (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  114. Change in Steady State Beta Cell Function (%B) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  115. Change in Steady State Beta Cell Function (%B) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.

  116. Change in Insulin Resistance (IR %) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  117. Change in Insulin Resistance (IR %) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).

  118. Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) [ Time Frame: Week -3, week 34 ]
    Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).

  119. Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) [ Time Frame: week -3, week 87 ]
    Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   23 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
  • Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
  • If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
  • FOR ALL COUNTRIES EXCEPT JAPAN:

Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):

  1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
  2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L)
  3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):

a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

Exclusion Criteria:

  • Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
  • Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file

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): NCT02229851


Locations
Show Show 117 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure' (1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] November 27, 2017
Statistical Analysis Plan  [PDF] November 27, 2017

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02229851    
Other Study ID Numbers: NN8640-4054
2013-002892-16 ( Registry Identifier: European Medicines Agency )
U1111-1145-0211 ( Other Identifier: World Health Organization (WHO) )
JapicCTI-152767 ( Registry Identifier: JAPIC )
First Posted: September 3, 2014    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on 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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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases