Acromegaly
Conditions
Brief summary
The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)
Interventions
120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1. * Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1. * Patients must have serum GH level \> 2.5 ng/mL AND serum IGF-1 level \> 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.
Exclusion criteria
* The patient has received pituitary radiation therapy of any kind at any time prior to visit 1. * The patient has received pituitary surgery within 3 months prior to visit 1. * The patient's serum creatinine is higher than 150 µmol/l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg. | Weeks 16, 18 & 20 |
| Acromegaly symptoms. | Weeks 16, 18 & 20 |
| Indices of insulin secretion & sensitivity | Weeks 16, 18 & 20 |
| Adverse events | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Serum lanreotide Autogel 120 mg concentrations. | Weeks 16, 18 & 20. |
| ECG and gallbladder ultrasound | Week 20 |
| Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN). | Weeks 16, 18 & 20. |
Countries
Mexico
Outcome results
None listed