Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly

Phase 1

Conditions: Cushing's disease and acromegaly
MedDRA version: 19.0Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 100000004860
MedDRA version: 19.0Level: LLTClassification code 10000600Term: Acromegaly and gigantismSystem Organ Class: 100000004860
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-002916-16-PL

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 133

Inclusion Criteria

Patients greater than or equal to 18 years old

Confirmed diagnosis of Cushing's disease or acromegaly

Additional inclusion criteria as per full protocol may apply.
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 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

Patients who require surgical intervention

Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry

HbA1c > 10 % at screening - Known hypersensitivity to somatostatin analogues

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of treatment with incretin based therapy vs. insulin on the 16-week glycemic control in patients with Cushing’s disease or acromegaly who develop or worsen hyperglycemia on pasireotide, and cannot be controlled by metformin alone or other background anti-diabetic treatments;Secondary Objective: 1. To evaluate the overall effect of anti-diabetic intervention on glycemic control in patients with Cushing’s disease or acromegaly<br>2. To evaluate the sustainability of glycemic control in the incretin based therapy arm and the insulin arm in Cushing’s disease patients treated with pasireotide s.c. and acromegaly patients treated with pasireotide LAR<br>3. To evaluate the safety and tolerability of pasireotide in combination with anti-diabetic treatments;Primary end point(s): Change in HbA1c from randomization to approximately 16 weeks;Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. <br>- Change in HbA1c and FPG from baseline to Core EOP (End of Phase) in patients who received pasireotide by treatment group<br>2.<br>- Proportion of patients with = 0.3% HbA1c increase from baseline to Core EOP per randomized arm <br>- Change in HbA1c and FPG from randomization over time and to Core EOP (only for FPG) per randomized arm<br>- Proportion of patients who required anti-diabetic rescue therapy with insulin per randomized arm<br>3.<br>- Toxicity will be assessed using NCI-CTC criteria version 4.03 for adverse events.<br>- Incidence of hypoglycemia events (# of episodes, # of patients)<br>- Clinical chemistry, hematology, urinalysis assessments<br>- ECGs<br>- Special safety assessments: Thyroid function tests, pancreatic safety tests (for anti-diabetic treatments) and gallbladder examinations;Timepoint(s) of evaluation of this end point: refer to section 10.5 of the protocol

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