Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia (NCT05928390) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
United States93 participantsStarted 2024-01-04
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓. (The previous inclusion criterion number 7 has been deleted).
✓. Patients in whom dietary control has not sufficiently controlled symptoms of PBH.
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:
✕. 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
What they're measuring
1
Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment.