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New treatment option for Postprandial Hypoglycemia
Official title Canakinumab for the Treatment of Postprandial Hypoglycemia
ClinicalTrials.gov ID: NCT05401578
What this study is testing
What is Canakinumab?
Canakinumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for postprandial hypoglycemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented...
- 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 likely can't join 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...
- Neutropenia (leukocyte count \< 1.5 × 109/L or ANC \< 0.5 × 109/L)
See the full eligibility 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...
- For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study
- Informed Consent as documented by signature
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Olten, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Olten, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.