The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Injections
Questionnaire
Diabetes and Endocrine Associates
La Mesa, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Denver VA Medical Center
Denver, Colorado, United States
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
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
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
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
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
Total Symptom Questionnaire Score at Week 24/Termination
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Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachussetts General Hospital
Boston, Massachusetts, United States
NYU School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Sisters of Charity Hospital, Buffalo
Williamsville, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
...and 3 more locations
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
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