CTRI/2015/02/005498
Recruiting
Phase 4
A multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushingâ??s disease or acromegaly
ovartis Healthcare Pvt Ltd0 sites133 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E220- Acromegaly and pituitary gigantismHealth Condition 2: null- Adult patients with Cushingâ??s disease or acromegaly
- Sponsor
- ovartis Healthcare Pvt Ltd
- Enrollment
- 133
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cushingâ??s disease population:
- •1\. Adult patients (age \>\= 18y) with confirmed diagnosis of Cushingâ??s disease
- •(persistent/recurrent or de Novo patients who are not considered candidates for pituitary
- •2\. Patients currently treated at screening visit with pasireotide s.c. should have an elevated
- •FPG \> ULN or a diagnosis of diabetes (FPG \>\= 126 mg/dL on two occasions or HbA1c \>\=
- •6\.5% or a random plasma glucose \>\= 200 mg/dL with classic symptoms of hyperglycemia
- •(polydipsia, polyphagia and polyuria)) during screening period.
- •3\. Previous exposure to pasireotide is allowed. In case pasireotide s.c. was discontinued
- •before screening a wash\-out period of at least 1 week before study entry (start of
- •pasireotide) has to be followed.
Exclusion Criteria
- •Cushingâ??s disease population
- •1\. Patients who are receiving other medical therapies for Cushingâ??s disease. All other
- •medical therapies for Cushingâ??s disease have to be discontinued at least 5 times the halflife
- •of the respective preparation before study entry (start of pasireotide).
- •Acromegaly population
- •2\. Patients who are receiving other medical therapies for acromegaly and not compliant with
- •the following rules:
- •Other medical therapies for acromegaly have to be discontinued at least 5 times the
- •elimination half\-life (t n half ) of the respective preparation before study entry (start of
- •pasireotide);
Outcomes
Primary Outcomes
Not specified
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