Acromegaly Insulin resistence MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10022489 Term: Insulin resistance
Conditions
Interventions
Trade Name: Ipstyl Autogel
Product Name: Ipstyl Autogel
Pharmaceutical Form: Solution for injection
Trade Name: Sandostatin LAR
Product Name: Sandostatin
Pharmaceutical Form: Powder and solvent for s
Sponsors
Aarhus University Hospital, Department M
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acromegalic patients on SA mono therapy, who are considered well-controlled. 1) a serum IGF-I 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergies to IMP Pregnancy Known liver disease Diabetes Mellitus type I
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if co-treatment of acromegalic patients, who beforehand are considered well-controlled on Somatostatin-analogue (SA) monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance.;Secondary Objective: To study effects of co-treatment on body compostion, intrahepatic and intramyocellular fat, substrate metabolism, quality of life and cost of medication. ;Primary end point(s): Insulin sensitvity and glucose tolerance. Cost of medication | — |
Countries
Denmark
Outcome results
None listed