Status:
RECRUITING
Canakinumab for the Treatment of Postprandial Hypoglycemia
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Postprandial Hypoglycemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed 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 Anakinr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05401578
Start Date
April 17 2023
End Date
May 31 2026
Last Update
January 29 2025
Active Locations (2)
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1
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
Basel, Switzerland, 4031
2
Cantonal Hospital Olten, Division of Endocrinology
Olten, Switzerland, 4600