Acromegaly
Conditions
Keywords
Acromegaly, Somatostatin Analogs, Somatuline® Autogel®, lanreotide, growth hormone, IGF-1, Inappropriate Growth Hormone Secretion Syndrome, Somatotropin Hypersecretion Syndrome, Inappropriate GH Secretion Syndrome
Brief summary
The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.
Detailed description
Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option. Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection. Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic. If Somatuline Autogel can be safely administered unsupervised, while maintaining disease control, this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic. This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control. Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values.
Interventions
DRUGSomatuline Autogel (lanreotide acetate)
Injections
BEHAVIORALHome administration
Questionnaire
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 must give signed informed consent before any study-related activities. * The partner, if applicable, must give signed informed consent before administration of Somatuline Autogel. * The subject must be able to understand the protocol requirements. * The subject must have a clinical diagnosis of acromegaly due to pituitary tumor. * The subject must be treated with a long-acting somatostatin analogue with or without a dopamine agonist and have been on the current medical regimen for at least 3 months prior to screening and have IGF-1 levels no higher than 10% above the upper limit of the normal range for age and gender at the screening visit or be somatostatin analogue naïve (if the subject is treated with a dopamine agonist he/she must have been on the current dose for at least 3 months prior to screening). * Subjects who are treated with a dopamine agonist have to stay on their current dose for the duration of the study. * Switch subjects must have had their last pre-study routine clinical treatment with Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment). * The subject must be able to store the study medication in a refrigerator in his/her own or his/her partner's home. * The subject must be ≥18 years of age. * Female subjects of childbearing potential must use adequate contraception. * Female subjects of childbearing potential who are taking oral contraceptives must agree to stay on their current contraceptive dose for the duration of the study. * The partner, if applicable, must be ≥18 years of age.
Exclusion criteria
* The subject has had pituitary surgery (adenomectomy) within 3 months prior to screening. * The subject has received pituitary radiotherapy within 3 years prior to screening. * The subject has received a GH receptor antagonist within 6 months prior to screening. * The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d * The subject is pregnant or breastfeeding. * The subject has clinically significant renal or hepatic abnormalities. * The subject has a symptomatic, untreated biliary lithiasis. * The subject has uncontrolled diabetes or thyroid disease. * The subject has a known hypersensitivity to any of the test materials or related compounds. * The subject is unable or unwilling to comply with the protocol. * The subject has received any investigational drug within 30 days prior to screening. * The subject has participated in a medical device study within 30 days prior to screening. * The subject has previously participated in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score. | 24 weeks | The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes'). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study | 24 weeks | Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1. |
| Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination. | 24 Weeks | Blood samples taken before and 60 and 120 min after glucose load from fasting patient. |
| Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score. | 24 weeks | Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient. |
| Total Symptom Questionnaire Score at Week 24/Termination | 24 Weeks | Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10. |
| Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination | 24 weeks | Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6. |
| Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients | 24 Weeks | Blood samples taken before and 60 and 120 min after glucose load from fasting patient. |
Countries
United States
Participant flow
Recruitment details
First patient enrolled on 6/28/2007 and last patient completed on 12/11/2008. The study enrolled patients with a diagnosis of acromegaly due to a pituitary tumor. patients were recruited from the patient populations of participating investigators and from referrals from other clinics and private practices. A competitive recruitment was used.
Pre-assignment details
Patient had been treated with a long-acting somatostatin analog for at least 3 months prior to Screening, must have had IGF-1 levels \< 10% above the upper limit of normal range, OR the patient was somatostatin analog-naïve (if the patient was treated with a dopamine agonist, he/she must have been on the dose for \>= 3 months prior to Screening)
Participants by arm
| Arm | Count |
|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Patient Decision | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Sponsor Decision | 1 |
Baseline characteristics
| Characteristic | Somatuline Autogel (Lanreotide Acetate) Injection |
|---|---|
| Age, Continuous | 53.1 Years STANDARD_DEVIATION 11.9 |
| Dopamine Agonist Treatment Missing | 15 Participants |
| Dopamine Agonist Treatment No | 33 Participants |
| Dopamine Agonist Treatment Yes | 11 Participants |
| Duration of Acromegaly | 7.8 Years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Previous Pituitary Surgery No | 7 participants |
| Previous Pituitary Surgery Yes | 52 participants |
| Prior Somatostatin Analogue Treatment Missing | 15 participants |
| Prior Somatostatin Analogue Treatment No | 6 participants |
| Prior Somatostatin Analogue Treatment Yes | 38 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 59 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 29 Participants |
| Time Since Last Pituitary Surgery | 6.7 Years STANDARD_DEVIATION 6.2 |
| Time Since Last Somatostatin Analogue Treatment | 78.8 Days STANDARD_DEVIATION 173.3 |
| Weight | 93.0 Kg STANDARD_DEVIATION 23.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 52 / 59 |
| serious Total, serious adverse events | 5 / 59 |
Outcome results
Primary
The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.
The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').
Time frame: 24 weeks
Population: All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score. | 98 Percentage of Participants |
Secondary
Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients
Blood samples taken before and 60 and 120 min after glucose load from fasting patient.
Time frame: 24 Weeks
Population: Patients switched directly from octreotide who had GH level measured at the end of study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients | -0.3 ng/mL | Standard Deviation 1.3 |
Secondary
Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.
Blood samples taken before and 60 and 120 min after glucose load from fasting patient.
Time frame: 24 Weeks
Population: Patients switched directly from octreotide who had GH level measured at the end of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination. | 89 Percent of Participants |
Secondary
Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study
Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.
Time frame: 24 weeks
Population: Patients switched directly from octreotide who had IGF-1 level measured at the end of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study | 94 Percent of Participants |
Secondary
Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.
Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.
Time frame: 24 weeks
Population: Patients switched directly from octreotide.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score. | 91 Percent of Participants |
Secondary
Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination
Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.
Time frame: 24 weeks
Population: All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination | 4.6 On a Scale from -6 to 6 | Standard Deviation 1.8 |
Secondary
Total Symptom Questionnaire Score at Week 24/Termination
Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.
Time frame: 24 Weeks
Population: All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somatuline Autogel (Lanreotide Acetate) Injection | Total Symptom Questionnaire Score at Week 24/Termination | 0.9 On a Scale from -10 to 10 | Standard Deviation 3.6 |