Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg
 with lanreotide 40mg PR in subjects with active acromegaly.
Inclusion Criteria:

 -  Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a
 central laboratory) as outlined below:

 -  A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the
 screening period (applicable to both treatment naïve subjects and subjects who
 have stopped treatment and undergone a washout period prior to Visit 1(Week -4).

 -  Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples
 taken at 0, 30, 60, 90 and 120 minutes) during the screening period.

 -  The subject has undergone surgical removal of an adenoma for acromegaly at least 3
 months prior to Screening, or is likely to require pituitary surgery in the future but
 not before completing at least 32 weeks of study treatment plus an additional follow
 up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for
 whom pituitary surgery is not an option (due to contraindications, refusal etc.) and
 is therefore never likely to undergo pituitary surgery.

 Exclusion Criteria:

 -  The subject has been treated with radiotherapy within 10 years prior to Screening.

 -  The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant,
 cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate
 release (IR) or bromocriptin within 2 weeks of Screening.

 -  The subject has a history of or currently presents with clinically significant
 ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute
 Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

 -  The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8.5%).