Canakinumab for the Treatment of Postprandial Hypoglycemia

ConditionPostprandial Hypoglycemia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity Hospital, Basel, Switzerland

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Any type of diabetes mellitus according to ADA criteria

Intolerance to the study drug

Signs of current infection

Any use of immunosuppressive medication

Trial design

Treatments tested in this trial

Canakinumab
Placebo (0.9% NaCl)

Treatment groups

56 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov