Canakinumab for the Treatment of Postprandial Hypoglycemia

Last updated: January 27, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes (Pediatric)

Hormone Deficiencies

Treatment

Canakinumab

Placebo (0.9% NaCl)

Clinical Study ID

NCT05401578
2021-02325; kt21Donath2
  • Ages 18-75
  • All Genders

Study 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 improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Canakinumab
Phase: 3
Study Start date:
April 17, 2023
Estimated Completion Date:
May 31, 2026

Study 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 Anakinra statistically significantly reduced the number of symptomatic hypoglycemia.

This randomized clinical trial is to directly evaluate clinical outcomes and patient-relevant benefits of treatment with the IL-1 receptor canakinumab over 28 days. 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.

For each subject, a maximum study duration of four months is anticipated with: screening visit 1 (1 h), screening phase (10-day screening phase for postprandial hypoglycemia using a blinded continuous glucose monitoring system (CGMS, Dexcom G6)), randomization/starting visit (visit 2, 1.5 h) followed by a 28 days intervention period with two additional study days (visit 3 and 4, 0.5 h, change of blinded continuous glucose monitoring system (CGFS sensor), diary documentation, adverse events) and end of treatment visit (visit 5). A follow-up visit will be done two months after the end of the treatment phase.

Connect with a study center

  • University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Olten, Division of Endocrinology

    Olten, 4600
    Switzerland

    Active - Recruiting

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