Acromegaly
Conditions
Brief summary
The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg
Interventions
120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has given written informed consent prior to any study-related procedures * The subject is male or female and is over 18 years of age * The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels * The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry * If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period
Exclusion criteria
* The subject has received radiation therapy to the pituitary gland before study entry * The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure * The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry * The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study * The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted) | At week 48 (End of Study) | A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks | During phase 2 of the study (up to week 48) | The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study. |
| Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels | At week 48 | The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48. |
| Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval | Baseline (visit 1) and week 48 | IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline |
| Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C | Baseline (visit 1) | — |
| Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24 | Baseline (visit 1) | — |
| Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | At baseline, week 24 and week 48 | Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms). |
| Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) | At week 24 | The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24. |
| Mean Changes From Baseline in Quality of Life Scores (SF-36) | At weeks 24 and 48 | Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst. |
| Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48 | At week 48 (End of Study) | The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48. |
| Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | At weeks 24 and 48 | AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline. IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline. Correlation presented is a Spearman correlation (non parametric). |
| Serum Growth Hormone (GH) Levels | At Baseline, week 24 and week 48 | — |
| Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | At weeks 24 and 48 | — |
| Subject Treatment Schedule Preference | At weeks 24 and 48 | At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks. At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study). |
| Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At weeks 24 and 48 | AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst. |
Countries
Brazil, Denmark, Finland, France, Greece, Latvia, Netherlands, Norway, Poland, Romania, Russia, Serbia, South Korea, Sweden
Participant flow
Recruitment details
Study initiation date: 06-Oct-2008. Study completion date: 20-May-2013. Screened subjects were 128 and screen failure subjects were 4. Subjects treated were 124 and subjects withdrawn early were 17. Subjects completed the study were 107.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: Lanreotide Autogel 120 mg Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided. | 15 |
| Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks Subjects with IGF-1 levels \>100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48. | 13 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks Subjects with IGF-1 levels \>50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48. | 70 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48. | 26 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Screening (Pre-assignment) Phase | Does not meet entry Criteria | 4 | 0 | 0 | 0 |
| Treatment Phase 1 | Adverse Event | 7 | 0 | 0 | 0 |
| Treatment Phase 1 | Does not meet entry Criteria | 1 | 0 | 0 | 0 |
| Treatment Phase 1 | Lack of Efficacy | 1 | 0 | 0 | 0 |
| Treatment Phase 1 | Protocol Violation | 1 | 0 | 0 | 0 |
| Treatment Phase 1 | Withdrawal by Subject | 5 | 0 | 0 | 0 |
| Treatment Phase 2 | Adverse Event | 0 | 0 | 1 | 0 |
| Treatment Phase 2 | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Phase 1: Lanreotide Autogel 120 mg | Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks |
|---|---|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 10.9 | 57.0 years STANDARD_DEVIATION 9.8 | 55.2 years STANDARD_DEVIATION 15.3 | 53.2 years STANDARD_DEVIATION 10.4 | 55.0 years STANDARD_DEVIATION 10.1 |
| Body Mass Index (BMI) | 28.8 kg/m^2 STANDARD_DEVIATION 5.6 | 27.0 kg/m^2 STANDARD_DEVIATION 4.3 | 28.4 kg/m^2 STANDARD_DEVIATION 2.9 | 29.5 kg/m^2 STANDARD_DEVIATION 6.5 | 29.2 kg/m^2 STANDARD_DEVIATION 4.1 |
| Region of Enrollment Brazil | 15 participants | 1 participants | 2 participants | 12 participants | 0 participants |
| Region of Enrollment Denmark | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Finland | 3 participants | 1 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment France | 14 participants | 4 participants | 1 participants | 9 participants | 0 participants |
| Region of Enrollment Greece | 9 participants | 4 participants | 2 participants | 3 participants | 0 participants |
| Region of Enrollment Korea, Republic of | 17 participants | 4 participants | 2 participants | 7 participants | 4 participants |
| Region of Enrollment Latvia | 10 participants | 2 participants | 1 participants | 7 participants | 0 participants |
| Region of Enrollment Netherlands | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment Norway | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment Poland | 12 participants | 2 participants | 1 participants | 8 participants | 1 participants |
| Region of Enrollment Romania | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Region of Enrollment Russian Federation | 20 participants | 4 participants | 1 participants | 12 participants | 3 participants |
| Region of Enrollment Serbia | 15 participants | 2 participants | 2 participants | 8 participants | 3 participants |
| Region of Enrollment Sweden | 4 participants | 0 participants | 1 participants | 3 participants | 0 participants |
| Sex: Female, Male Female | 78 Participants | 20 Participants | 9 Participants | 41 Participants | 8 Participants |
| Sex: Female, Male Male | 46 Participants | 6 Participants | 6 Participants | 29 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 10 / 13 | 48 / 70 | 20 / 26 |
| serious Total, serious adverse events | 3 / 15 | 2 / 13 | 4 / 70 | 2 / 26 |
Outcome results
Primary
Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)
A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)
Time frame: At week 48 (End of Study)
Population: Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).~n = Number of subjects at the visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted) | Intention-to-Treat (n=124) | 75.8 Percentage of subjects |
| Overall Study | Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted) | Modified Intention-to-Treat (n=109) | 86.2 Percentage of subjects |
Secondary
Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit
AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline. IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline. Correlation presented is a Spearman correlation (non parametric).
Time frame: At weeks 24 and 48
Population: ITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 24: Phase I / Group A (n=8) | 0.43 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 24: Phase I / Group B (n=55) | -0.02 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 24: Phase I / Group C (n=21) | -0.41 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 24: Overall study (n=85) | -0.01 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 48: Phase I / Group A (n=8) | 0.69 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 48: Phase I / Group B (n=53) | -0.06 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 48: Phase I / Group C (n=21) | -0.09 Correlation coefficient |
| Overall Study | Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit | Week 48: Overall study (n=82) | -0.01 Correlation coefficient |
Secondary
Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24
Time frame: Baseline (visit 1)
Population: ITT population. n = Number of subjects at the visit.~These subjects entered in phase 2~One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Overall Study | Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24 | Uncontrolled IGF-1 levels at Week 24 (n=14) | 95.92 Percentage of ULN |
| Overall Study | Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24 | Normalized IGF-1 levels at Week 24 (A+B+C) (n=108) | 67.49 Percentage of ULN |
| Overall Study | Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24 | Difference in Mean Baseline | 28.43 Percentage of ULN |
Comparison: Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.p-value: 0.0103t-test, 2 sided
Secondary
Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval
IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline
Time frame: Baseline (visit 1) and week 48
Population: MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval | -1.70 Percentage of ULN | Standard Deviation 18.55 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval | 5.74 Percentage of ULN | Standard Deviation 30.48 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval | -4.33 Percentage of ULN | Standard Deviation 28.14 |
Comparison: One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.p-value: 0.0013ANCOVA
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Mean Changes From Baseline in Quality of Life Scores (AcroQoL)
AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.
Time frame: At weeks 24 and 48
Population: ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 \& did not move onto phase 2.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 24 (n=1, 9, 55, 21, and 86) | 21.59 Units on a scale | — |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 48 (n=0, 9, 53, 21, and 83) | NA Units on a scale | — |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 24 (n=1, 9, 55, 21, and 86) | -2.15 Units on a scale | Standard Deviation 9.58 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 48 (n=0, 9, 53, 21, and 83) | 1.31 Units on a scale | Standard Deviation 10.67 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 24 (n=1, 9, 55, 21, and 86) | -0.27 Units on a scale | Standard Deviation 11.73 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 48 (n=0, 9, 53, 21, and 83) | -1.32 Units on a scale | Standard Deviation 10.17 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 48 (n=0, 9, 53, 21, and 83) | -1.52 Units on a scale | Standard Deviation 10.22 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 24 (n=1, 9, 55, 21, and 86) | -0.84 Units on a scale | Standard Deviation 11 |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 24 (n=1, 9, 55, 21, and 86) | -0.35 Units on a scale | Standard Deviation 11.43 |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (AcroQoL) | At week 48 (n=0, 9, 53, 21, and 83) | -1.08 Units on a scale | Standard Deviation 10.15 |
Secondary
Mean Changes From Baseline in Quality of Life Scores (SF-36)
Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.
Time frame: At weeks 24 and 48
Population: ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 24 (n=3, 13, 70, 26, and 112) | -0.66 Units on a scale | Standard Deviation 39.14 |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 48 (n=0, 13, 68, 26, and 107) | NA Units on a scale | — |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 24 (n=3, 13, 70, 26, and 112) | 4.91 Units on a scale | Standard Deviation 22.64 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 48 (n=0, 13, 68, 26, and 107) | 4.96 Units on a scale | Standard Deviation 20.35 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 24 (n=3, 13, 70, 26, and 112) | 1.79 Units on a scale | Standard Deviation 13.54 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 48 (n=0, 13, 68, 26, and 107) | -0.61 Units on a scale | Standard Deviation 12.09 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 48 (n=0, 13, 68, 26, and 107) | -0.62 Units on a scale | Standard Deviation 14.76 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 24 (n=3, 13, 70, 26, and 112) | -2.75 Units on a scale | Standard Deviation 14.87 |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 24 (n=3, 13, 70, 26, and 112) | 1.03 Units on a scale | Standard Deviation 15.89 |
| Overall Study | Mean Changes From Baseline in Quality of Life Scores (SF-36) | At week 48 (n=0, 13, 68, 26, and 107) | 0.06 Units on a scale | Standard Deviation 13.93 |
Secondary
Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks
The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.
Time frame: During phase 2 of the study (up to week 48)
Population: ITT population. n = Number of subjects at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks | Intention-to-Treat (n=124) | 78.2 Percentage of subjects |
| Overall Study | Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks | Modified Intention-to-Treat (n=109) | 88.1 Percentage of subjects |
Secondary
Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels
The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.
Time frame: At week 48
Population: ITT population. n = Number of subjects at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels | Intention-to-Treat (n=124) | 20.2 Percentage of subjects |
| Overall Study | Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels | Modified Intention-to-Treat (n=109) | 22.9 Percentage of subjects |
Secondary
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
Time frame: At weeks 24 and 48
Population: n = Number of subjects at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 48 - Phase I / Group B (n=70) | 92.6 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 24 - Phase I only (n=15) | 66.7 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 24 - Phase I / Group A (n=13) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 24 - Phase I / Group B (n=70) | 91.4 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 24 - Phase I / Group C (n=26) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 24 - Overall study (n=124) | 93.8 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 48 - Phase I / Group A (n=13) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 48 - Phase I / Group C (n=26) | 96.2 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | ITT: Week 48 - Overall study (n=124) | 94.4 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 24 - Phase I / Group A (n=13) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 24 - Phase I / Group B (n=70) | 91.4 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 24 - Phase I / Group C (n=26) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 24 - Overall study (n=109) | 94.5 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 48 - Phase I / Group A (n=13) | 100.0 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 48 - Phase I / Group B (n=70) | 92.6 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 48 - Phase I / Group C (n=26) | 96.2 Percentage of subjects |
| Overall Study | Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL | MITT: Week 48 - Overall study (n=109) | 94.4 Percentage of subjects |
Secondary
Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.
Time frame: At week 24
Population: ITT population. n = Number of subjects at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) | Intention-to-Treat (n=124) | 88.7 Percentage of subjects |
| Overall Study | Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted) | Modified Intention-to-Treat (n=109) | 100 Percentage of subjects |
Secondary
Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48
The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.
Time frame: At week 48 (End of Study)
Population: MITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48 | Phase I / Group A (n=9) | 44.4 Percentage of subjects |
| Overall Study | Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48 | Phase I / Group B (n=55) | 47.2 Percentage of subjects |
| Overall Study | Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48 | Phase I / Group C (n=21) | 38.1 Percentage of subjects |
| Overall Study | Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48 | Overall study (n=85) | 44.6 Percentage of subjects |
Secondary
Serum Growth Hormone (GH) Levels
Time frame: At Baseline, week 24 and week 48
Population: ITT population. n = Number of subjects at the visit.~Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Week 24 (n=0, 13, 70, 26, and 109) | NA ng/mL | — |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Baseline (n=15, 13, 70, 26, and 124) | 1.04 ng/mL | Standard Deviation 1.02 |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Week 48 (n=0, 13, 68, 26, and 107) | NA ng/mL | — |
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Baseline (n=0, 13, 70, 26, and 109) | NA ng/mL | — |
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Week 48 (n=0, 13, 68, 26, and 107) | NA ng/mL | — |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Week 24 (n=3, 13, 70, 26, and 112) | 4.89 ng/mL | Standard Deviation 7.42 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | ITT - Baseline (n=15, 13, 70, 26, and 124) | 0.92 ng/mL | Standard Deviation 0.68 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 24 (n=0, 13, 70, 26, and 109) | 0.90 ng/mL | Standard Deviation 0.41 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 24 (n=3, 13, 70, 26, and 112) | 0.90 ng/mL | Standard Deviation 0.41 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.69 ng/mL | Standard Deviation 0.31 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.69 ng/mL | Standard Deviation 0.31 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Serum Growth Hormone (GH) Levels | MITT - Baseline (n=0, 13, 70, 26, and 109) | 0.92 ng/mL | Standard Deviation 0.68 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.99 ng/mL | Standard Deviation 0.99 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 24 (n=3, 13, 70, 26, and 112) | 0.95 ng/mL | Standard Deviation 0.89 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Baseline (n=15, 13, 70, 26, and 124) | 0.92 ng/mL | Standard Deviation 1.16 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 24 (n=0, 13, 70, 26, and 109) | 0.95 ng/mL | Standard Deviation 0.89 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.99 ng/mL | Standard Deviation 0.99 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Baseline (n=0, 13, 70, 26, and 109) | 0.92 ng/mL | Standard Deviation 1.16 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Baseline (n=15, 13, 70, 26, and 124) | 1.08 ng/mL | Standard Deviation 1.17 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 24 (n=3, 13, 70, 26, and 112) | 0.67 ng/mL | Standard Deviation 0.55 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | ITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.83 ng/mL | Standard Deviation 0.69 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Baseline (n=0, 13, 70, 26, and 109) | 1.08 ng/mL | Standard Deviation 1.17 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 24 (n=0, 13, 70, 26, and 109) | 0.67 ng/mL | Standard Deviation 0.55 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Serum Growth Hormone (GH) Levels | MITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.83 ng/mL | Standard Deviation 0.69 |
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Week 24 (n=0, 13, 70, 26, and 109) | 0.88 ng/mL | Standard Deviation 0.78 |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.92 ng/mL | Standard Deviation 0.87 |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Week 24 (n=3, 13, 70, 26, and 112) | 0.99 ng/mL | Standard Deviation 1.42 |
| Overall Study | Serum Growth Hormone (GH) Levels | ITT - Baseline (n=15, 13, 70, 26, and 124) | 0.97 ng/mL | Standard Deviation 1.09 |
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Baseline (n=0, 13, 70, 26, and 109) | 0.96 ng/mL | Standard Deviation 1.11 |
| Overall Study | Serum Growth Hormone (GH) Levels | MITT - Week 48 (n=0, 13, 68, 26, and 107) | 0.92 ng/mL | Standard Deviation 0.87 |
Secondary
Subject Treatment Schedule Preference
At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks. At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study).
Time frame: At weeks 24 and 48
Population: ITT population. n = Number of subjects at the visit.~Lan: Lanreotide~W: Week~Inj: Injection~Wks: Weeks~Phs: Phase~Grp: Group~evy: every
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Subject Treatment Schedule Preference | W24:Oct-LAR IM inj evy 4 wks Phs 1 only (n=15) | 20 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Lan Autogel inj evy 6 wks Phs 1 only (n=15) | 80 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13) | 7.7 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13) | 92.3 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70) | 10.3 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70) | 85.3 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Non precised Phs 1/Grp B (n=70) | 4.4 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26) | 3.8 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Lan Autogel inj every 6 wks Phs 1/Grp C(n=26) | 96.2 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W 24:Oct-LAR IM inj evy 4 wks-Overall study(n=124) | 8.9 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W24:Lan Autogel inj evy 6 wks-Overall study(n=124) | 88.4 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W 24: Non precised - Overall study (n=124) | 2.7 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13) | 15.4 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13) | 76.9 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Non precised Phs 1/Grp A (n=13) | 7.7 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70) | 14.7 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 4 wks Phs 1/Grp B(n=70) | 1.5 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70) | 77.9 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Non precised Phs 1/Grp B (n=70) | 5.9 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26) | 7.7 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 8 wks Phs 1/Grp C(n=26) | 92.3 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Oct-LAR IM inj evy 4 wks-Overall study(n=124) | 13.1 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 4 wks-Overall study(n=124) | 10.3 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 6 wks-Overall study(n=124) | 49.5 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Lan Autogel inj evy 8 wks-Overall study(n=124) | 22.4 Percentage of subjects |
| Overall Study | Subject Treatment Schedule Preference | W48:Non precised-Overall study (n=124) | 4.7 Percentage of subjects |
Secondary
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).
Time frame: At baseline, week 24 and week 48
Population: ITT population.~Number of Participants Analyzed:~Phase 1 in week 24: 3~Phase 2 (Group A) in week 24: 13~Phase 2 (Group B) in week 24: 69~Phase 2 (Group C) in week 24: 25~Phase 2 (Group A) in week 48: 13~Phase 2 (Group B) in week 48: 68~Phase 2 (Group C) in week 48: 26~NA = Not Applicable
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Soft tissue swelling | 1.33 Units on a scale | Standard Deviation 1.53 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Fatigue | 2.33 Units on a scale | Standard Deviation 1.53 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Arthralgia | 2.73 Units on a scale | Standard Deviation 3.17 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Arthralgia | NA Units on a scale | — |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Excessive perspiration | 2.00 Units on a scale | Standard Deviation 2 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Headache | 2.67 Units on a scale | Standard Deviation 1.53 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Soft tissue swelling | NA Units on a scale | — |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Excessive perspiration | 2.80 Units on a scale | Standard Deviation 2.93 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Headache | 2.73 Units on a scale | Standard Deviation 2.71 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Fatigue | NA Units on a scale | — |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Excessive perspiration | NA Units on a scale | — |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Fatigue | 3.40 Units on a scale | Standard Deviation 2.85 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Soft tissue swelling | 1.13 Units on a scale | Standard Deviation 1.77 |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Headache | NA Units on a scale | — |
| Overall Study | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Arthralgia | 2.00 Units on a scale | Standard Deviation 2.65 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Soft tissue swelling | 2.77 Units on a scale | Standard Deviation 2.2 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Arthralgia | 3.46 Units on a scale | Standard Deviation 2.57 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Headache | 2.15 Units on a scale | Standard Deviation 1.72 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Excessive perspiration | 1.92 Units on a scale | Standard Deviation 2.5 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Fatigue | 4.23 Units on a scale | Standard Deviation 1.48 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Arthralgia | 3.46 Units on a scale | Standard Deviation 2.3 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Headache | 1.38 Units on a scale | Standard Deviation 1.45 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Excessive perspiration | 2.08 Units on a scale | Standard Deviation 2.02 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Fatigue | 3.85 Units on a scale | Standard Deviation 1.86 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Soft tissue swelling | 2.46 Units on a scale | Standard Deviation 1.9 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Arthralgia | 3.62 Units on a scale | Standard Deviation 2.79 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Headache | 1.77 Units on a scale | Standard Deviation 1.92 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Excessive perspiration | 2.31 Units on a scale | Standard Deviation 2.02 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Fatigue | 3.77 Units on a scale | Standard Deviation 2.55 |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Soft tissue swelling | 2.85 Units on a scale | Standard Deviation 2.08 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Soft tissue swelling | 2.10 Units on a scale | Standard Deviation 2.39 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Headache | 1.80 Units on a scale | Standard Deviation 1.73 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Excessive perspiration | 2.50 Units on a scale | Standard Deviation 2.13 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Arthralgia | 3.09 Units on a scale | Standard Deviation 2.66 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Excessive perspiration | 2.41 Units on a scale | Standard Deviation 2.18 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Arthralgia | 3.60 Units on a scale | Standard Deviation 2.6 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Soft tissue swelling | 1.71 Units on a scale | Standard Deviation 2.17 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Fatigue | 3.16 Units on a scale | Standard Deviation 2.32 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Headache | 1.93 Units on a scale | Standard Deviation 1.9 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Fatigue | 3.27 Units on a scale | Standard Deviation 2.36 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Arthralgia | 3.13 Units on a scale | Standard Deviation 2.42 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Soft tissue swelling | 1.81 Units on a scale | Standard Deviation 2.02 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Excessive perspiration | 2.25 Units on a scale | Standard Deviation 2.21 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Headache | 2.32 Units on a scale | Standard Deviation 2.22 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Fatigue | 3.36 Units on a scale | Standard Deviation 2.56 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Soft tissue swelling | 1.42 Units on a scale | Standard Deviation 1.88 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Fatigue | 4.08 Units on a scale | Standard Deviation 2.4 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Arthralgia | 4.04 Units on a scale | Standard Deviation 2.24 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Soft tissue swelling | 1.76 Units on a scale | Standard Deviation 2.13 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Fatigue | 3.31 Units on a scale | Standard Deviation 2.63 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Arthralgia | 3.68 Units on a scale | Standard Deviation 2.53 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Soft tissue swelling | 1.62 Units on a scale | Standard Deviation 2.02 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Headache | 2.62 Units on a scale | Standard Deviation 2.08 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Excessive perspiration | 2.08 Units on a scale | Standard Deviation 2.21 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Excessive perspiration | 2.50 Units on a scale | Standard Deviation 2.4 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Arthralgia | 4.42 Units on a scale | Standard Deviation 2.35 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Headache | 2.04 Units on a scale | Standard Deviation 1.9 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 48 - Fatigue | 3.92 Units on a scale | Standard Deviation 2.17 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Week 24 - Excessive perspiration | 2.64 Units on a scale | Standard Deviation 2.34 |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia) | Baseline - Headache | 2.04 Units on a scale | Standard Deviation 2.11 |
Secondary
Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C
Time frame: Baseline (visit 1)
Population: MITT population.~One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Overall Study | Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C | 98.69 Percentage of ULN |
| Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks | Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C | 67.75 Percentage of ULN |
| Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks | Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C | 51.30 Percentage of ULN |
p-value: 0.0009t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: 0.017t-test, 2 sided