Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. \< 3.0 mmol/l and at least 5 hypoglycemic episodes per week despite dietary modification
• For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study
• Informed Consent as documented by signature
Locations
Other Locations
Switzerland
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
RECRUITING
Basel
Cantonal Hospital Olten, Division of Endocrinology
RECRUITING
Olten
Contact Information
Primary
Marc Y Donath, Prof. Dr.
marc.donath@usb.ch
+41 61 265 25 25
Backup
Susanne Ruesch
susanne.ruesch@usb.ch
+41 61 556 5655
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 56
Treatments
Active_comparator: Study Intervention: Canakinumab
Standard dose of canakinumab (Ilaris®; Novartis Switzerland), i. e. 150 mg subcutaneously.~Canakinumab (Ilaris®, Novartis) is a recombinant, human monoclonal IgG1/kappa antibody inhibiting IL-1β by neutralizing its biological activity through binding to the IL-1 receptor.
Placebo_comparator: Control Intervention: Placebo (0.9% NaCl)
Placebo: 1 ml of 0.9 % NaCl
Authors
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland