Canakinumab for the Treatment of Postprandial Hypoglycemia

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Postprandial Hypoglycemia

In brief

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.

Key facts

Study ID

NCT05401578

Run by

University Hospital, Basel, Switzerland

People needed

56

Starts

2023-04-17

Expected to finish

2026-05-31

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 (all remaining 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 or participants 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 30 days 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 dependent persons

Where it is running

• University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism — Basel, Switzerland (enrolling)
• Cantonal Hospital Olten, Division of Endocrinology — Olten, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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