Co-treatment with pegvisomant and a somatostatin analogue (SA) in SA-responsive acromegalic patients: impact on insulin sensitivity, glucose tolerance, and pharmacoeconomics
- Conditions
- AcromegalyInsulin resistenceMedDRA version: 9.1Level: LLTClassification code 10000599Term: AcromegalyMedDRA version: 9.1Level: LLTClassification code 10022489Term: Insulin resistance
- Registration Number
- EUCTR2007-005244-25-DK
- Lead Sponsor
- Aarhus University Hospital, Department M
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Acromegalic patients on SA mono therapy, who are considered well-controlled.
1) a serum IGF-I < 2 SDS above the upper normal range or
2) a nadir GH < 0.5 µg/l.
3) Borderline patients, who do not entirely meet these criteria, may be included.
This could mean patients who have been on SA mono therapy with appropriate
symptom relief for more than 3 years.
Written consent
Age > 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
Known allergies to IMP
Pregnancy
Known liver disease
Diabetes Mellitus type I
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method