Canakinumab for the Treatment of Postprandial Hypoglycemia

Recruiting Phase 3 Interventional Study
Postprandial Hypoglycemia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
56 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 chil…
Contacts

Marc Y Donath, Prof. Dr.

+41 61 265 25 25

marc.donath@usb.ch

CONTACT

Susanne Ruesch

+41 61 556 5655

susanne.ruesch@usb.ch

CONTACT