Ultrasound Guided Octreotide LAR Injection in Acromegaly

Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly

Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.

Inclusion Criteria:

• Diagnosis of active acromegaly based on evidence of a pituitary tumor
• Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test
• Previous treatment with a stable dose of octreotide LAR for at least 3 months
• No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity

Exclusion Criteria:

• Uncontrolled diabetes mellitus
• Pregnant or breast feeding
• Current gallstones
• History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic steatosis
• Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
• History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy
• History of investigational drugs administered or received within 30 days of study entry
• Known hypersensitivity to octreotide LAR
• Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor