NCT05928390进行中（未招募）2 期
A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 29
- 主要终点
- Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment.
研究概览
简要总结
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods
-
19 weeks for the Core Phase. It is composed of:
-
a Screening period: a maximum of 3 weeks
-
a Run-in period (no treatment): 4 weeks
-
a Blinded Treatment Phase: 12 weeks
-
36 weeks Extension Phase = an open-label Treatment period
-
4 weeks for the safety follow-up period (without any treatment).
详细描述
Subjects with post-bariatric hypoglycemia will be screened for participation in this trial. Eligible patients will complete the rest of the Core phase by entering a run-in period of 4 weeks without any treatment.
At the end of the run-in period, participants will be randomized to receive in a blinded manner either pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg or Placebo subcutaneously three times a day (prior to each meal).
Participants will blindly self-administer their treatment for a total of 12 weeks when the primary endpoint will be assessed.
All participants completing the core phase will be offered to enter the extension phase. Participants will openly self-administer pasireotide 50 µg or pasireotide 100 µg or pasireotide 200 µg subcutaneously three times a day for a total of 36 weeks of treatment. There will be no more placebo during this extension phase of treatment.
Dose changes/adjustments will be possible only during the extension phase and the decision to change the dose of pasireotide will be left to the investigator's judgment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or- non-pregnant female patients ≥ 18 years of age
- •Patients able to provide and have provided signed written informed consent prior to study participation.
- •Patients capable of self-injecting subcutaneously. Specific training to self-inject the study drug will be provided.
- •Post-bariatric surgery more than 6 months prior to screening
- •Patients with a medically documented diagnosis of PBH and documented glucose measurement (less than 70 mg/dl or 3.9 mmol/L) with symptoms of hypoglycaemia, and resolution following administration of rescue carbohydrates
- •Patients must have ≥ 4 post-prandial hypoglycaemia during the 28-day run-in period (in average ≥1 event over a 7-day week) defined as:
- •Blood glucose less than 54 mg/dL (3.0 mmol/L) as measured by SMBG (level 2) or
- •Level 3 hypoglycaemic event
- •(The previous inclusion criterion number 7 has been deleted).
- •Patients in whom dietary control has not sufficiently controlled symptoms of PBH.
- •Karnofsky Performance Status ≥ 60 (i.e., requires occasional assistance, but is able to care for most of their personal needs)
- •Patients who received other therapies for PBH (such as acarbose, gama guar, pectin, diazoxide) must have stopped all treatments and such treatments are prohibited for a period of at least 2 weeks or 5 half-life times prior to entering the screening period.
- •GLP-1 antagonists and GLP-1 agonists for patients who have been treated with in the past for the indication of PBH, are prohibited for a period of at least 4 weeks before the start of the screening period.
- •SGLT2 inhibitors (glifozins) for patients who have been treated with in the past for the indication of PBH, are prohibited for a period of at least 4 weeks before the start of the screening period.
- •Patients who have been treated with somatostatin receptor analogues in the past, must have an appropriate interval between the last administration of somatostatin receptor analogues treatment and the start of the run-in period as follows:
- •Octreotide s.c. for ≥ 72 hours
- •Octreotide LAR for ≥ 56 days (8 weeks)
- •Lanreotide Autogel for ≥ 98 days (14 weeks)
- •Lanreotide SR ≥ 28 days (4 weeks)
- •Pasireotide s.c. for ≥ 72 hours (3 days)
- •Pasireotide LAR for ≥ 84 days (12 weeks)
- •Exclusion Criteria :
- •Bariatric patients who have lap band.
- •Patients with a current diagnosis of uncontrolled Diabetes Mellitus. However, diabetic patients in remission, as defined below, are eligible:
- •With an HbA1c at screening less than 6.5%
- •Not taking any medications for hyperglycaemia for at least 3 months prior to screening.
- •Their qualifying Level 3 hypoglycaemia events (see above) must have occurred at least 1 month after the discontinuation of the glucose lowering agent(s).
- •Patients with hypocortisolism, as defined by serum cortisol levels minor of LLN with presence of clinical signs and symptoms of adrenal insufficiency (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia, or hypoglycaemia) as judged by the Investigators
- •(The previous exclusion criterion number 4 has been deleted).
- •(The previous exclusion criterion number 5 has been deleted).
- •Patients who have a known hypersensitivity to somatostatin receptor analogues.
- •Patients currently using medications that may interfere with glucose metabolism within 5 half-lives of drug.
- •Patients with history of or current insulinoma.
- •Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study such as:
- •Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive HIV test result (ELISA and Western blot). An HIV test will not be required; however, previous medical history will be reviewed.
- •Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment.
- •Life-threatening autoimmune and ischemic disorders.
- •Inadequate end organ function as defined by:
- •Inadequate bone marrow function:
- •WBC less than 3.0 x 109/L
- •Absolute Neutrophil Count (ANC) less than 1.5 x 109/L
- •Platelets less than100 x 109/L
- •Hgb less than 11 g/dL
- •INR ≥ 1.5
- •eGFR less than 30 mL/min/1.73m2
- •Alkaline phosphatase more than 2.5 x ULN
- •Serum total bilirubin more than1.5 x ULN
- •ALT and AST more than 1.5 x ULN
- •History of liver disease, such as cirrhosis or chronic active hepatitis B andC
- •Presence of Hepatitis B surface antigen (HbsAg) and/ or Presence of Hepatitis C antibody test (anti-HCV). Patients with positive HCV Ab must undergo reflex HCV RNA testing, and patients with HCV RNA positivity will be excluded. Patients with positive HCV Ab and negative HCV RNA are eligible.
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排除标准
- 未提供
研究组 & 干预措施
Pasireotide s.c. 50 mcg
Experimental
Pasireotide 50 mcg s.c. tid
干预措施: Pasireotide Diaspartate (Drug)
Pasireotide 100 mcg
Experimental
Pasireotide 100 mcg s.c. tid
干预措施: Pasireotide Diaspartate (Drug)
Pasireotide 200 mcg
Experimental
Pasireotide 200 mcg s.c. tid
干预措施: Pasireotide Diaspartate (Drug)
Placebo
Placebo Comparator
Placebo s.c. tid
干预措施: Pasireotide Diaspartate (Drug)
结局指标
主要结局
Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment.
时间窗: at baseline and at 12 weeks
Change in the blood glucose levels, as measured by the peak to nadir glucose AUC during MMTT
次要结局
- KEY SECONDARY_CORE PHASE: Evaluation the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline(at baseline and at 12 weeks)
- CORE PHASE: Evaluation of the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline and the MMTT(baseline and 12 weeks)
- CORE PHASE: Evaluation of the efficacy of pasireotide s.c. on the change from baseline of level 2 hypoglycaemic events during a MMTT in patients with PBH(at 12 weeks)
- CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (SF-36 score)(at 12 weeks)
- CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Dumping Score Questionnaire)(at 12 weeks)
- CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Patient Global Assessment)(at 12 weeks)
- CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Hypoglycaemia Fear Survey-II) from baseline(at 12 weeks)
- CORE PHASE: Evaluation of the safety profile of pasireotide s.c (AEs)(for 12 weeks)
- EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (AEs)(for 36 weeks)
- CORE PHASE: Evaluation of the safety profile of pasireotide s.c (Labs)(for 12 weeks)
- EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (Labs)(for 36 weeks)
- CORE PHASE: Evaluation of the safety profile of pasireotide s.c (ECG)(for 12 weeks)
- EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (ECG)(for 36 weeks)
- CORE PHASE: Evaluation of the safety profile of pasireotide s.c (imaging)(for 12 weeks)
- EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period:(imaging)(for 36 weeks)
研究者
研究点 (29)
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