Canakinumab for the Treatment of Postprandial Hypoglycemia

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT05401578
Phase
PHASE3
Status
Recruiting
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Conditions

  • Postprandial Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    Canakinumab (Ilaris®, Novartis Switzerland) will be used in the recommended standard dose of 150 mg subcutaneously once. Patients will be randomized at visit 2 = Baseline to either placebo (1 ml 0.9 % saline solution s.c.) or treatment with 1 ml 150 mg canakinumab solution s.c. in a 1:1 manner.
  • Placebo (0.9% NaCl) — DRUG
    1 ml 0.9 % saline solution s.c. Patients will be randomized at visit 2 = Baseline to either placebo (1 ml 0.9 % saline solution s.c.) or treatment with 1 ml 150 mg canakinumab solution s.c. in a 1:1 manner.

Study Details

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 Dates

Start date
Apr 17, 2023
Status verified
Jan 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Study Intervention: Canakinumab
    Standard dose of canakinumab (Ilaris®; Novartis Switzerland), i. e. 150 mg subcutaneously. Canakinumab (Ilaris®, Novartis) is a recombinant, human monoclonal IgG1/kappa antibody inhibiting IL-1β by neutralizing its biological activity through binding to the IL-1 receptor.
  • Placebo Comparator: Control Intervention: Placebo (0.9% NaCl)
    Placebo: 1 ml of 0.9 % NaCl

Primary Outcome Measure

Change in Health related quality of life (mental health) [ Time Frame: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days) ]

Central Contacts