Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
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.
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.