CTRI/2015/02/005498招募中4 期
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 个研究点目标入组 133 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 133
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •Acromegaly population:
- •4. Adult patients (age >= 18 y) with confirmed diagnosis of acromegaly. De Novo patients
- •(with no prior pituitary surgery) can be included if they are not considered candidates for
- •pituitary surgery or have refused surgery.
- •5. Patients currently treated at screening visit with pasireotide LAR should have 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.
- •Inclusion criteria for both Cushingâ??s disease and acromegaly population:
- •7. Patients with either Type 1 or Type 2 diabetes currently being treated with insulin (basal insulin with or without prandial insulin) are eligible for study entry. However, these
- •patients will be treated in the non-randomized observational arm.
- •8. Patients with Type 2 diabetes being treated with anti-diabetic agents (including metformin)
- •other than incretin based therapies are eligible for study entry and randomization.
- •9. Written informed consent must be obtained prior to any study related procedure.
- •10. If patients were treated with insulin only for an acute medical need and insulin was
- •discontinued after that, then a wash-out period of at least 48 hours before study entry (start
- •of pasireotide) has to be followed. These patients will be eligible for randomization.
排除标准
- •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);
- •Other SSAs (octreotide, lanreotide) have to be discontinued at least 5 times the
- •elimination half-life of the respective formulation before study entry (8 weeks
- •washout for octreotide LAR and lanreotide autogel);
- •Dopamine agonists (bromocriptine, cabergoline) or pegvisomant (INN) will only be
- •accepted provided the dose regimen is stable from at least 4 weeks before study entry
- •and throughout the study.
- •3 Patients who require surgical intervention
- •4 Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to
- •study entry
- •5 HbA1c less than 10 percent at screening
- •6 Patients with life-threatening diabetic ketoacidosis or diabetic hyperosmolar coma
- •7 Any major surgery or surgical therapy for any cause within 4 weeks of signing the informed
- •consent (patients must recover from the surgery and be in good clinical condition before
- •entering the study).
- •8 Participation in any clinical protocol and or receiving an investigational drug within 4
- •weeks prior to dosing or longer (a minimal wash out of 5 t n half of the investigational drug is
- •mandatory and local regulation should be followed).
- •9 Known hypersensitivity to somatostatin analogues.
- •10 Patients who are hypothyroid and have clinical symptoms of hypothyroidism despite
- •adequate replacement therapy
- •11 Life-threatening autoimmune disorders
- •12 History of liver disease, such as severe hepatic impairment (Child-Pugh C, cirrhosis, or
- •chronic active hepatitis B or C [presence of hepatitis B surface antigen (HbsAg) or
- •hepatitis C antibody (anti-HCV)]).
- •13 Cholelithiasis, or acute or chronic pancreatitis.
- •14 Cardiac or repolarization abnormality
- •15 History of HIV infection, including a positive HIV test result (Elisa and Western blot). An HIV test is not required; however, previous medical history should be reviewed.
- •16 Screening ALT or AST less than 2x ULN
- •17 Screening total bilirubin less than 1.5x ULN
- •18 Renal dysfunction as defined by local metformin label (E.g., As per SmPC, creatinine
- •clearance than less 60 mL min; As per US package insert, serum creatinine than less 1.5 mg dL
- •(males), less than 1.4 mg dL (females)) at screening.
- •19 Inadequate bone marrow function
- •20 Abnormal coagulation function (PT and PTT elevated by 30 percent above normal limits, or
- •INR less than equal 1.3 except for patients on anti-coagulant therapy. Patients on anticoagulant therapy
- •must be stable for at least 1 month prior to study entry).
- •21 Any known contraindication to DPP-4 inhibitor, GLP-1 receptor agonists or insulin,
- •including but not limited to:
研究者
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