Acromegaly
Conditions
Brief summary
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.
Interventions
DRUGBIM 23A760
Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* IGF-1 ≥1.3 x upper limit normal (ULN) * Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT) * Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
Exclusion criteria
* The patient has received long acting somatostatin analogues within 6 months of study entry * The patient has undergone radiotherapy at any time prior to study entry * The time between pituitary surgery (if any) and study entry is less than 6 weeks * The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | At Month 3 | — |
| Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6 | Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline |
| Changes in IGF-1 | Baseline (Day 1) and Month 6 | — |
| Percentage Change in Ring Finger Circumference | Baseline (Day 1) and Month 6 | Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline. |
| Number of Subjects Reported Adverse Events During the Study | Up to Visit 10 (An average of 6.5 Months) | For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study. |
Countries
Belgium, Brazil, Czechia, France, Latvia, Lithuania, Mexico, Netherlands, Poland, Romania, Sweden, Ukraine, United States
Participant flow
Recruitment details
This was a multicentre study conducted at 36 investigational sites in 16 countries: Czech Republic, Lithuania, Poland, Romania, Ukraine, Latvia, USA, United Kingdom (UK), Italy, Mexico, Brazil, France, Belgium, Netherlands, Germany and Sweden.
Pre-assignment details
Screened subjects were 109 and screen failures were 33. Subjects randomised and treated in part A were 76. Subjects completed part A were 21 and subjects entered Part B were 12, excluding 9 subjects, who chose not to continue in part B. No subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: BIM 23A760 1 mg BIM 23A760 1 mg subcutaneous 24 weekly injections. | 19 |
| Arm B: BIM 23A760 2 mg BIM 23A760 2 mg subcutaneous 24 weekly injections. | 19 |
| Arm C: BIM 23A760 4 mg BIM 23A760 4 mg subcutaneous 24 weekly injections. | 18 |
| Arm D: BIM 23A760 6 mg BIM 23A760 6 mg subcutaneous 24 weekly injections.. | 20 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| ITT (Intention-to-Treat) - Part A | Adverse Event | 0 | 1 | 0 | 0 |
| ITT (Intention-to-Treat) - Part A | Lost to Follow-up | 1 | 0 | 0 | 0 |
| ITT (Intention-to-Treat) - Part A | Withdrawal by Subject | 0 | 0 | 0 | 1 |
| ITT (Intention-to-Treat) - Part A | Withdrawn - Study termination by sponsor | 13 | 12 | 13 | 14 |
| ITT (Intention-to-Treat) - Part B | Withdrawal by Subject | 0 | 0 | 0 | 1 |
| ITT (Intention-to-Treat) - Part B | Withdrawn - Study termination by sponsor | 4 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Arm B: BIM 23A760 2 mg | Arm A: BIM 23A760 1 mg | Arm C: BIM 23A760 4 mg | Arm D: BIM 23A760 6 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.7 Years STANDARD_DEVIATION 11.2 | 42.8 Years STANDARD_DEVIATION 11.3 | 40.3 Years STANDARD_DEVIATION 11.3 | 43.4 Years STANDARD_DEVIATION 12.9 | 43.8 Years STANDARD_DEVIATION 11.9 |
| Baseline Prolactin Males (n=A:9,B:6,C:12, D:7, and Total:34) | 34.113 μg/L STANDARD_DEVIATION 49.588 | 11.506 μg/L STANDARD_DEVIATION 14.233 | 41.657 μg/L STANDARD_DEVIATION 60.965 | 83.036 μg/L STANDARD_DEVIATION 131.024 | 40.86 μg/L STANDARD_DEVIATION 72.52 |
| Baseline Prolactin Post-menopausal female(n=A:6,B:9,C:2,D:6,&Totl:23) | 16.409 μg/L STANDARD_DEVIATION 24.232 | 8.420 μg/L STANDARD_DEVIATION 3.167 | 7.870 μg/L STANDARD_DEVIATION 0.693 | 25.118 μg/L STANDARD_DEVIATION 39.986 | 15.85 μg/L STANDARD_DEVIATION 25.89 |
| Baseline Prolactin Pre-menopausal female(n=A:4,B:4,C:4,D:7,&Totl:19) | 26.158 μg/L STANDARD_DEVIATION 19.798 | 19.838 μg/L STANDARD_DEVIATION 15.247 | 35.608 μg/L STANDARD_DEVIATION 25.536 | 23.634 μg/L STANDARD_DEVIATION 23.778 | 25.88 μg/L STANDARD_DEVIATION 21.94 |
| Diabetic status at entry Diabetic | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 7 Participants |
| Diabetic status at entry Non-diabetic | 18 Participants | 17 Participants | 16 Participants | 18 Participants | 69 Participants |
| Growth Hormone (GH) | 20.99 ng/mL STANDARD_DEVIATION 59.28 | 16.79 ng/mL STANDARD_DEVIATION 24.56 | 28.60 ng/mL STANDARD_DEVIATION 64.83 | 26.59 ng/mL STANDARD_DEVIATION 63.47 | 23.21 ng/mL STANDARD_DEVIATION 55.54 |
| Height | 170.3 cm STANDARD_DEVIATION 13.2 | 170.1 cm STANDARD_DEVIATION 8.1 | 175.0 cm STANDARD_DEVIATION 10.1 | 166.4 cm STANDARD_DEVIATION 8.6 | 170.3 cm STANDARD_DEVIATION 10.4 |
| Insulin-like growth factor 1 (IGF-1) | 315 Percentage of ULN(Upper limit of number) | 307 Percentage of ULN(Upper limit of number) | 382 Percentage of ULN(Upper limit of number) | 335 Percentage of ULN(Upper limit of number) | 333 Percentage of ULN(Upper limit of number) |
| Race/Ethnicity, Customized Caucasian/White | 14 Participants | 17 Participants | 13 Participants | 18 Participants | 62 Participants |
| Race/Ethnicity, Customized Multiple race | 5 Participants | 2 Participants | 5 Participants | 2 Participants | 14 Participants |
| Region of Enrollment Belgium | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Brazil | 1 Participants | 1 Participants | 3 Participants | 5 Participants | 10 Participants |
| Region of Enrollment Czech Republic | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Region of Enrollment France | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Latvia | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Lithuania | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 6 Participants |
| Region of Enrollment Mexico | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 11 Participants |
| Region of Enrollment Netherlands | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Poland | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment Romania | 3 Participants | 4 Participants | 1 Participants | 4 Participants | 12 Participants |
| Region of Enrollment Sweden | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Ukraine | 4 Participants | 6 Participants | 4 Participants | 6 Participants | 20 Participants |
| Region of Enrollment United States | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Ring Finger Circumference | 68.5 mm STANDARD_DEVIATION 6.2 | 70.2 mm STANDARD_DEVIATION 5.6 | 71.2 mm STANDARD_DEVIATION 4.7 | 68.4 mm STANDARD_DEVIATION 6.3 | 69.53 mm STANDARD_DEVIATION 5.75 |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 6 Participants | 13 Participants | 42 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 12 Participants | 7 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 19 | 12 / 19 | 12 / 18 | 15 / 20 | 50 / 76 | 0 / 3 | 1 / 4 | 4 / 5 | 5 / 12 |
| serious Total, serious adverse events | 1 / 19 | 2 / 19 | 0 / 18 | 0 / 20 | 3 / 76 | 0 / 3 | 0 / 4 | 2 / 5 | 2 / 12 |
Outcome results
Primary
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 6
Population: Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 16.7 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 83.3 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100.0 Percentage of subjects |
Secondary
Changes in IGF-1
Time frame: Baseline (Day 1) and Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Changes in IGF-1 | -51.30 Percentage of ULN | Standard Deviation 136.66 |
| Arm B: BIM 23A760 2 mg | Changes in IGF-1 | -53.31 Percentage of ULN | Standard Deviation 80.57 |
| Arm C: BIM 23A760 4 mg | Changes in IGF-1 | -40.53 Percentage of ULN | Standard Deviation 56.65 |
| Arm D: BIM 23A760 6 mg | Changes in IGF-1 | -85.91 Percentage of ULN | Standard Deviation 95.34 |
Secondary
Number of Subjects Reported Adverse Events During the Study
For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.
Time frame: Up to Visit 10 (An average of 6.5 Months)
Population: Safety Population~Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 3 Participants |
| Arm A: BIM 23A760 1 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 8 Participants |
| Arm A: BIM 23A760 1 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 0 Participants |
| Arm A: BIM 23A760 1 mg | Number of Subjects Reported Adverse Events During the Study | Related | 7 Participants |
| Arm A: BIM 23A760 1 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 11 Participants |
| Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 9 Participants |
| Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 1 Participants |
| Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 9 Participants |
| Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 8 Participants |
| Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Related | 8 Participants |
| Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Related | 10 Participants |
| Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 12 Participants |
| Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 1 Participants |
| Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 6 Participants |
| Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 4 Participants |
| Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 11 Participants |
| Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 7 Participants |
| Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Related | 11 Participants |
| Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 2 Participants |
| Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 15 Participants |
| Overall - Part A | Number of Subjects Reported Adverse Events During the Study | Mild | 47 Participants |
| Overall - Part A | Number of Subjects Reported Adverse Events During the Study | Severe | 4 Participants |
| Overall - Part A | Number of Subjects Reported Adverse Events During the Study | Moderate | 22 Participants |
| Overall - Part A | Number of Subjects Reported Adverse Events During the Study | Related | 36 Participants |
| Overall - Part A | Number of Subjects Reported Adverse Events During the Study | Not Related | 34 Participants |
| Part B: Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 0 Participants |
| Part B: Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 0 Participants |
| Part B: Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Related | 0 Participants |
| Part B: Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 0 Participants |
| Part B: Arm B: BIM 23A760 2 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 0 Participants |
| Part B: Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 1 Participants |
| Part B: Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 0 Participants |
| Part B: Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 0 Participants |
| Part B: Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Related | 0 Participants |
| Part B: Arm C: BIM 23A760 4 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 1 Participants |
| Part B: Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Mild | 1 Participants |
| Part B: Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Moderate | 3 Participants |
| Part B: Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Not Related | 3 Participants |
| Part B: Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Related | 1 Participants |
| Part B: Arm D: BIM 23A760 6 mg | Number of Subjects Reported Adverse Events During the Study | Severe | 0 Participants |
| Overall - Part B | Number of Subjects Reported Adverse Events During the Study | Not Related | 4 Participants |
| Overall - Part B | Number of Subjects Reported Adverse Events During the Study | Severe | 0 Participants |
| Overall - Part B | Number of Subjects Reported Adverse Events During the Study | Related | 1 Participants |
| Overall - Part B | Number of Subjects Reported Adverse Events During the Study | Moderate | 3 Participants |
| Overall - Part B | Number of Subjects Reported Adverse Events During the Study | Mild | 2 Participants |
Secondary
Percentage Change in Ring Finger Circumference
Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.
Time frame: Baseline (Day 1) and Month 6
Population: ITT population. N=Number of subjects attended Month 6 (visit 9).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Percentage Change in Ring Finger Circumference | -3.518 Percentage of Change in Ring Finger circ | Standard Deviation 3.688 |
| Arm B: BIM 23A760 2 mg | Percentage Change in Ring Finger Circumference | -1.469 Percentage of Change in Ring Finger circ | Standard Deviation 2.12 |
| Arm C: BIM 23A760 4 mg | Percentage Change in Ring Finger Circumference | -0.678 Percentage of Change in Ring Finger circ | Standard Deviation 2.409 |
| Arm D: BIM 23A760 6 mg | Percentage Change in Ring Finger Circumference | -4.003 Percentage of Change in Ring Finger circ | Standard Deviation 3.367 |
Secondary
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 3
Population: ITT population. N=Number of subjects attended Month 3 (visit 7).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 7.7 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 92.3 Percentage of subjects |
Secondary
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1
Time frame: At Month 1
Population: ITT population. N=Number of subjects attended Month 1 (visit 5).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 5.3 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm A: BIM 23A760 1 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 94.7 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm B: BIM 23A760 2 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 100 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 0 Percentage of subjects |
| Arm C: BIM 23A760 4 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes | 5.0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Missing | 0 Percentage of subjects |
| Arm D: BIM 23A760 6 mg | Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 | Mean GH ≤2.5 ng/mL and Normalised IGF-1: No | 95.0 Percentage of subjects |
Secondary
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6
Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline
Time frame: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Population: N=Number of patients randomised to treatment in IGF-1 \<2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1≥2.5 x UL | -26.14 Percentage of change in mean GH | Standard Deviation 39.6 |
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1<2.5 x ULN | 29.26 Percentage of change in mean GH | Standard Deviation 45.97 |
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1≥2.5 x UL | -36.15 Percentage of change in mean GH | Standard Deviation 45.63 |
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1<2.5 x ULN | 71.44 Percentage of change in mean GH | Standard Deviation 35.97 |
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1≥2.5 x UL | -39.20 Percentage of change in mean GH | Standard Deviation 30.33 |
| Arm A: BIM 23A760 1 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1<2.5 x ULN | 4.10 Percentage of change in mean GH | Standard Deviation 53.03 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1<2.5 x ULN | -18.99 Percentage of change in mean GH | Standard Deviation 21.36 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1<2.5 x ULN | -0.55 Percentage of change in mean GH | Standard Deviation 23.98 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1<2.5 x ULN | 3.32 Percentage of change in mean GH | Standard Deviation 9.09 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1≥2.5 x UL | -22.24 Percentage of change in mean GH | Standard Deviation 34.72 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1≥2.5 x UL | 15.28 Percentage of change in mean GH | Standard Deviation 82.56 |
| Arm B: BIM 23A760 2 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1≥2.5 x UL | -22.35 Percentage of change in mean GH | Standard Deviation 31.71 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1<2.5 x ULN | -9.92 Percentage of change in mean GH | Standard Deviation 71.51 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1<2.5 x ULN | 17.48 Percentage of change in mean GH | Standard Deviation 127.97 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1≥2.5 x UL | -7.64 Percentage of change in mean GH | Standard Deviation 30.11 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1≥2.5 x UL | -10.64 Percentage of change in mean GH | Standard Deviation 51.18 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1≥2.5 x UL | -10.43 Percentage of change in mean GH | Standard Deviation 28.9 |
| Arm C: BIM 23A760 4 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1<2.5 x ULN | 82.45 Percentage of change in mean GH | Standard Deviation 0 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1≥2.5 x UL | -19.47 Percentage of change in mean GH | Standard Deviation 68.9 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1<2.5 x ULN | -17.59 Percentage of change in mean GH | Standard Deviation 41.82 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1<2.5 x ULN | -28.84 Percentage of change in mean GH | Standard Deviation 43.25 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 6: IGF-1<2.5 x ULN | -38.21 Percentage of change in mean GH | Standard Deviation 27.27 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 1: IGF-1≥2.5 x UL | -23.63 Percentage of change in mean GH | Standard Deviation 39.57 |
| Arm D: BIM 23A760 6 mg | Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 | At Month 3: IGF-1≥2.5 x UL | -20.53 Percentage of change in mean GH | Standard Deviation 42.23 |