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
- Conditions
- Post-Bariatric HypoglycaemiaMedDRA version: 21.1Level: PTClassification code: 10059035Term: Postprandial hypoglycaemia Class: 100000004861MedDRA version: 21.1Level: PTClassification code: 10077216Term: Hyperinsulinaemic hypoglycaemia Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-505316-37-00
- Lead Sponsor
- Recordati AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Written informed consent prior to any screening procedures must be obtained, 9.Karnofsky Performance Status = 60 (i.e., requires occasional assistance, but is able to care for most of their personal needs)., 10.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 prior to entering the screening period., 11.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., 12.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., 13.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 screening 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)., 1.Male or non-pregnant female patients = 18 years of age., 2.Patients able to provide and have provided signed written informed consent prior to study participation., 3.Patients capable of self-injecting subcutaneously. Specific training to self-inject the study drug will be provided., 4.Post-bariatric surgery more than 6 months prior to screening., 5.Patients with a documented diagnosis of PBH defined as having: •postprandial neuroglycopenia occurring >1 hour after meals •no hypoglycaemia (glucose value < 60 mg/dl or 3.3 mmol/L if asymptomatic – OR < 70 mg/dL or 3.9 mmol/L if symptomatic) in fasting condition of at least 8 hours •documented history of hypoglycaemia based on oglucose value < 50mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis – OR oglucose value < 60 mg/dL or 3.3 mmol/L at 60, 90, 120, 150, or 180 min during an OGTT (oral glucose tolerance test) – OR – oglucose value < 54 mg/dL or 3 mmol/L at 60, 90, 120, 150 or 180 min during a 3-hour MMTT (mixed meal tolerance test)., 6.Patients must have at least one glucose level < 54 mg/dL or 3 mmol/L at 60, 90, 120, 150, or 180 min during the 3-hour MMTT at screening., 7.Evidence of previous level 3 hypoglycaemia events at any time., 8.Patients who have failed diet recommended by the treating physician for the PBH.
1.Bariatric patients who have lap band., 10.History of liver disease, such as cirrhosis or chronic active hepatitis B and C., 11.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., 12.History of, or current alcohol and/or drug misuse/abuse within the past 12 months. A drug/alcohol test will not be required; however, previous medical history will be reviewed., 13.Patients with symptomatic cholelithiasis and/ or acute or chronic pancreatitis., 14.Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits)., 15.Patients on continuous anticoagulation therapy. Patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion (patients receiving aspirin once a day are allowed to be enrolled)., 16.Patients who are hypothyroid and not on adequate replacement therapy., 17.Patients who have undergone major surgery/surgical therapy for any cause within 1 month. Patients should have recovered from the surgery and be in good clinical condition before entering the study., 18.Patients requiring gastrostomy tube feedings., 19.Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study., 2.Patients with a current diagnosis of uncontrolled Diabetes Mellitus. However, diabetic patients in remission, as defined below, are eligible: •With an HbA1c at screening <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)., 20.Clinically significant abnormal laboratory values considered by the Investigator or the medical monitor of the sponsor to be clinically significant or which could have affected the interpretation of the study results, 21.Bradycardia and QT-related exclusion criteria: •Patients with long QT syndrome or QTcF >450 ms for male and QTcF >460 ms for female detected at screening. •Patients with uncontrolled or significant cardiac disease, including recent myocardial infarction, unstable angina, congestive heart failure, clinically significant/symptomatic heart rate < 50 bpm, or high-grade AV block, sustained ventricular tachycardia, ventricular fibrillation. •History of syncope or family history of idiopathic sudden death. •Sustained or clinically significant cardiac arrhythmias. •Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, or cardiac failure. •Family history of long QT syndrome. •Concomitant medications known to prolong the QT interval. •Hypokalaemia (Potassium < or = 3.5 mEq/L). •Hypomagnesemia (Magnesium < 0.7 mmol/L)., 22.Participation in any clinical investigation within 4 weeks prior to screening or longer if required by local regulation. (Use of an investigational drug within 1 month prior to screening)., 23.Significant acute illness within the two weeks prior to dosing., 24.Female patients who are pregnant, intending to become pregnant or breastfe
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