Inclusion Criteria:

• Male and female patients ≥18 years old
• Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
• Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
• Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
• Patients have provided written informed consent

Exclusion Criteria:

• Uncontrolled diabetes mellitus
• Patients who are pregnant or lactating
• Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
• Patients with current gallstones
• Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
• Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
• Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
• Patients who have received other investigational drugs administered or received within 30 days of study entry
• Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment

Inclusion Criteria:

• Male and female patients ≥18 years old
• Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH >1 mcg/l at 120 Minutes of a two hour OGTT.
• Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.
• Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects
• Patients have provided written informed consent

Exclusion Criteria:

• Uncontrolled diabetes mellitus
• Patients who are pregnant or lactating
• Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound
• Patients with current gallstones
• Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
• Patients with a history of hepatic disease (patients with minimal, i.e., <3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)
• Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy
• Patients who have received other investigational drugs administered or received within 30 days of study entry
• Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment

Inclusion Criteria:

1. Patients with written informed consent prior to any study related activity
2. Patients with inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
3. Patients treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to randomization. The maximum indicated dose for octreotide LAR is 30mg and for lanreotide ATG is 120 mg
4. Patients with diagnosis of pituitary micro- or macro adenoma. Patients can have been previously submitted to surgery

Exclusion Criteria:

1. Patients who have received pasireotide (SOM 230) prior to enrolment
2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to randomization (8 weeks wash out period)
3. Patients with compression of the optic chiasm causing acute clinically significant visual field defects
4. Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
5. Patients who have received pituitary irradiation within 10 years prior to randomization
6. Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks prior to randomization
7. Patients who are hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy

Other protocol-defined inclusion/exclusion criteria may apply

Inclusion Criteria:

• Currently enrolled in the Extension Phase of Study IP107-001 and received at least one 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.
• Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107 001.
• In the opinion of the Investigator; subject has no unstable chronic medical conditions and no clinically significant findings that would preclude subject's participation in the study.
• Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.

Exclusion Criteria:

• Pituitary surgery less than 3 months prior to enrollment into this study
• Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])
• Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
• Acute myocardial infarction within 3 months of Screening
• Uncontrolled diabetes defined as having an HbA1c ≥9%
• Symptomatic cholelithiasis
• History of drug or alcohol abuse
• Received any investigational drug or participated in another clinical trial except for study IP107 001 within 30 days of enrollment into this study
• Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time prior to enrollment into this study
• Receiving pegvisomant, dopamine agonist or other therapy in combination with somatostatin to control GH or IGF-1 levels prior to enrollment into this study
• History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or, terminal systemic disease that limits life expectancy, or may interfere with the conduct of the study, or subjects who are incarcerated in penal institutions or are committed to mental institutions
• Women who are pregnant or lactating. For females of childbearing potential, a positive pregnancy test prior to enrollment, or an unwillingness to use accepted forms of reliable birth control for study duration (including bilateral tubal ligation, use of oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
• An unwillingness on the part of a male subject to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom and spermicide and another form of contraception (eg, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study

Inclusion Criteria:

• Age 18-75
• History of acromegaly with biochemical cure documented with a normal OGTT and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these
• At the time of enrollment a minimum of 6 months must have elapsed since surgery.
• No malignancy on colonoscopy performed since the diagnosis of acromegaly
• GHD due to surgical or radiation treatment
• GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GHRH plus arginine stimulation test
• GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies

Exclusion Criteria:

• Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
• History of malignancy except for non-melanoma skin cancer
• Hemoglobin <11.0 gm/dl
• Uncontrolled hypertension
• Hepatic or renal disease (AST/ALT > 3x ULN or creatinine level >2.5 mg/dl)
• Congestive heart failure (New York Heart Association's classification system Class II-IV CHF will be excluded)
• Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
• Initiation or discontinuation of gonadal steroid therapy within 3 months of entry
• Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance
• Pregnancy or nursing
• Active carpal tunnel syndrome
• Subjects who have received GH therapy within one year prior to entry into the study
• For female subjects age >40 a screening mammogram must have been obtained within one year prior to their baseline visit.
• Sensitivity to m-cresol

Inclusion Criteria:

• Active acromegaly due to excess GH produced by a pituitary adenoma.
• Patients must have an elevated IGF-I compared to age and gender matched controls (as supplied by the laboratory) and fail to suppress GH to below 1 ng/ml after a standard 75g oral glucose tolerance test.
• Type 2 diabetes mellitus, defined by elevated fasting glucose ≥ 126 mg/dl (verified by two historical measurements), or plasma glucose ≥ 200 mg/dl two hours after a 75 g oral glucose load, or a random glucose ≥ 200 mg/dl.

Exclusion Criteria:

1. Acromegaly Group

   • Current medical therapy for acromegaly including dopamine agonists, somatostatin analogues, or growth hormone antagonists.

   • For subjects on current therapy the following washout periods may be used:

     • Cabergoline: 4 weeks
     • Bromocriptine: 1 week
     • Sandostatin LAR: 3 months
     • Short-acting octreotide: 1 week
     • Lanreotide: 3 months
     • Pegvisomant: 4 weeks
   • Subjects with a history of surgical therapy for treatment of acromegaly must have verification of active disease with verified elevated IGF-I for the subjects' age and gender compared to healthy controls (as supplied by the laboratory) (two measures) as well as a failure to suppress GH to below 1 ng/ml after OGTT.
   • Current treatment for insulin resistance or type 2 DM including oral or injection medications.
   • Fasting glucose ≥ 126 mg/dl at screening evaluation.
   • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
   • Pregnancy or breast feeding.

2. Type 2 diabetes mellitus group

   • Patients taking non-insulin medications for diabetes treatment will be excluded.
   • Diagnosis of acromegaly.
   • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
   • Pregnancy or breast feeding.

3. Healthy Control Group

   • History of diabetes mellitus or impaired glucose tolerance, history of acromegaly.
   • Fasting glucose ≥ 126 mg/dl at screening evaluation.
   • Evidence of hepatic or renal disease defined as elevated transaminases, elevated serum creatinine.
   • Pregnancy or breast feeding.

Enrollment will include subjects diagnosed with acromegaly or carcinoid syndrome who are taking long-acting somatostatin analogs for at least three months prior to study enrollment.

Inclusion Criteria:

• Diagnosis of acromegaly or carcinoid syndrome
• Treatment with somatostatin analog therapy (must have established a stable dose of three or more injections on the same dose prior to study enrollment)
• Healthy control subjects

Exclusion Criteria:

• Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
• Use of medication for the treatment of insulin resistance or diabetes