Canakinumab for the Treatment of Postprandial Hypoglycemia

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 dietarymodification

• For women with child-bearing potential, willingness to use contraceptive measuresadequate to prevent pregnancy during the study

• Informed Consent as documented by signature

Exclusion Criteria:

• Any type of diabetes mellitus according to ADA criteria

• Intolerance to the study drug

• Signs of current infection

• Any use of immunosuppressive medication

• Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (allremaining drugs have to be discontinued four half-life times before screening phase)

• Neutropenia (leukocyte count < 1.5 × 109/L or ANC < 0.5 × 109/L)

• Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females)

• Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, AST/ALT > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)

• Uncontrolled congestive heart failure

• Uncontrolled malignant disease

• Currently pregnant or breastfeeding

• Known or suspected non-compliance, drug or alcohol abuse

• Meeting the criteria for vulnerability (e.g. participants incapable of judgment orparticipants under tutelage)

• Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, dementia, etc.

• Participation in another clinical trial using investigational drugs in the last 30days or planned participation in the next 60 days

• Previous enrolment into the current study,

• Enrolment of the investigator, his/her family members, employees and other dependentpersons