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Canakinumab for the Treatment of Postprandial Hypoglycemia — CanpHy  

Postprandial Hypoglycemia Clinical Trial

Official title:
Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study

Clinical Trial 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.

Clinical Trial Description

Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. In a former study, the IL-1 receptor antagonist Anakinra statistically significantly reduced the number of symptomatic hypoglycemia. This randomized clinical trial is to directly evaluate clinical outcomes and patient-relevant benefits of treatment with the IL-1 receptor canakinumab over 28 days. 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. For each subject, a maximum study duration of four months is anticipated with: screening visit 1 (1 h), screening phase (10-day screening phase for postprandial hypoglycemia using a blinded continuous glucose monitoring system (CGMS, Dexcom G6)), randomization/starting visit (visit 2, 1.5 h) followed by a 28 days intervention period with two additional study days (visit 3 and 4, 0.5 h, change of blinded continuous glucose monitoring system (CGFS sensor), diary documentation, adverse events) and end of treatment visit (visit 5). A follow-up visit will be done two months after the end of the treatment phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05401578
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Marc Y Donath, Prof. Dr. med.
Phone +41 61 265 25 25
Email marc.donath@usb.ch
Status Recruiting
Phase Phase 3
Start date April 17, 2023
Completion date May 2024
View Details
See also
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Completed NCT01162499 - Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia N/A