Trial Information

A Multicenter, Open, Prospective, Observational Study to Investigate the Effect of Lanreotide Autogel 120 mg on Control of GH and IGF-I Excess and Tumor Shrinkage in Newly Diagnosed Patients With Acromegaly

This is an open, prospective, observational, clinical study to be performed in two
University Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the
efficacy of the ATG 120 mg on control of GH and IGF-I excess in acromegaly according with
the currently accepted criteria (12) and on tumor shrinkage. The secondary objectives are to
assess improvement of clinical symptoms and safety profile. The study population will
consist of at least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th
2007. Patients give their written informed consent prior to entering into the study. The
study was performed according to the principles defined by the declaration The safety
population, as defined by the protocol, consists of patients who received at least one study
drug dosing.

Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals
(starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of
ATG. IGF-I levels are assessed as a single sample taken at each visit at the same time as
the first GH sample. All hormonal parameters were assessed in a central laboratory
(University of Genoa).

Improvement in clinical symptoms is considered on the basis of a semiquantitative scale for
asthenia, hyperhidrosis, headache, swelling of extremities, arthralgia, paraesthesia, carpal
tunnel syndrome: symptoms were graded as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.

Any adverse event (AE) during the study is monitored and reported by the investigators.
Safety, evaluated by local laboratory data, is assessed at inclusion and at the final visit
by: hematology: erythrocytes, leukocytes, platelets, haemoglobin, hematocrit; biochemistry:
glucose, creatinine, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT),
aspartate aminotransferase (AST), electrolytes (sodium, potassium, calcium, phosphorous)
glycosylated haemoglobin, triglycerides, total and high density lipoproteins (HDL)
cholesterol, blood amylase, iron, transferrin, prothrombin; glucose and insulin
concentrations; hormonal evaluation: thyroid-stimulating hormone (TSH), free
triiodothyronine (FT3), free triiodothyronine (FT4), follicle stimulating hormone (FSH) and
luteinizing hormone (LH) levels. Safety related to gallbladder is assessed by ultrasound
examination performed at inclusion and at the end of the study.