Postprandial HypoglycemiaPhase 3CanpHyNCT05401578
Canakinumab for the Treatment of Postprandial Hypoglycemia
A Phase 3 study testing Canakinumab in people with Postprandial Hypoglycemia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postprandial Hypoglycemia
- What is being tested?
- Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 17 Apr 2023to 31 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
Basel, 4031
Marc Y Donath, Prof. Dr. med., +41 61 265 25 25, marc.donath@usb.ch
Susanne Ruesch, +41 61 556 5655, susanne.ruesch@usb.ch
- Recruiting
Cantonal Hospital Olten, Division of Endocrinology
Olten, 4600
Matthias Hepprich, PD Dr., +41 62 311 47 33, matthias.hepprich@spital.so.ch
Matthias Hepprich, PD Dr.
About this study
Official title: Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study
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.
Read the 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 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.
- Conditions
- Postprandial Hypoglycemia
- Being tested
- Canakinumab, Placebo (0.9% NaCl)
- Keywords
- bariatric surgery, IL-1 receptor antagonist, postbariatric hypoglycemia, canakinumab, quality of life
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
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 group | Role | What they receive |
|---|---|---|
| Study Intervention: Canakinumab | Active comparator | 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. Receives: Drug: Canakinumab |
| Control Intervention: Placebo (0.9% NaCl) | Placebo comparator | Placebo: 1 ml of 0.9 % NaCl Receives: Drug: Placebo (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health related quality of life (mental health)
Health related quality of life (mental health; as assessed by the SF-36 mental health component score; MCS). The lower the score the more disability.
Measured: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Change in Health related quality of life (physical health)
Health related quality of life (physical health; as assessed by the SF-36 physical component score; PCS). The lower the score the more disability.
Measured: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Number of Hypoglycemic events
Hypoglycemic events defined as glucose values below 3.0 mmol/l
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Secondary outcomes (11)
Change in Postprandial Symptoms of hypoglycemia according to Edinburgh Hypoglycemia Scale (EHSS)
Postprandial Symptoms of hypoglycemia defined as acute onset of typical symptoms according to Edinburgh Hypoglycemia Scale. The EHSS is an instrument to evaluate patients' experiences of symptoms in a typical hypoglycemic episode. It comprises 11 symptoms divided into three domains-neuroglycopenic, autonomic, and malaise, which are evaluated by a 7-point Likert scale "1= Not at all, 7= Very severely". The postprandial period is defined as 3 hours following meal intake.
Measured: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Change in Hypoglycemia unawareness (measured by modified Clarke Score)
The Clarke questionnaire consists of eight specific items characterizing awareness of hypoglycemia giving a total score of "0" to "7 (score ≥4 suggests inadequate hypoglycemia awareness; a score ≤2 suggests normal hypoglycemia awareness
Measured: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Change in Fear of hypoglycemia (measured on a scale of 0 to 10)
The fear of hypoglycemia will be assessed by using a 10-cm long visual analogue scale graded from "0 - no fear at all" to "10 - massive fear"
Measured: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Time below range (TBR; % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Time below range (TBR; % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Pattern of sensor glucose
Pattern of sensor glucose, defined as the slope of postprandial increase (calculated as the maximal rate of increase observed over 20min in the postprandial period) and decrease CanpHy-Study Version 1.2 of date 02.04.2022 Page 26 of 47 (calculated as the maximal rate of decrease over 20min in the postprandial period). The postprandial period is defined as 3 hours following meal intake.
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Glycemic variability (defined as the coefficient of variation (CV) of sensor glucose)
Glycemic variability (defined as the coefficient of variation (CV) of sensor glucose)
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Mean amplitude of sensor glucose excursions (MAGE)
Mean amplitude of sensor glucose excursions (MAGE)
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Change in Body weight
Change in Body weight
Measured: From Baseline (study day 1) to day 29 (-1 /+2 days)
Total adverse events
Total adverse events
Measured: From Baseline (study day 1) to Follow- up (day 90 +/- 11 days)
Serious adverse events
Number of Serious adverse events
Measured: From Baseline (study day 1) to Follow- up (day 90 +/- 11 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start17 Apr 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, multicenter, 1:1 randomized, placebo-controlled, parallel-group, double-blind superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Y Donath, Prof. Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401578
- Sponsor's protocol ID
- 2021-02325; kt21Donath2
- Acronym
- CanpHy
- Status last verified
- Jan 2025
- First submitted
- 23 May 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities. Individual data are accessible on request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study
- ClinicalTrials.gov ID
- NCT05401578
- Acronym / sponsor ID
- CanpHy / 2021-02325; kt21Donath2
- Conditions
- Postprandial Hypoglycemia
- Keywords
- bariatric surgery, IL-1 receptor antagonist, postbariatric hypoglycemia, canakinumab, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- National, multicenter, 1:1 randomized, placebo-controlled, parallel-group, double-blind superiority trial
| Arm | Type | Receives |
|---|---|---|
| Study Intervention: Canakinumab | Active comparator | Drug: CanakinumabStandard 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. |
| Control Intervention: Placebo (0.9% NaCl) | Placebo comparator | Drug: Placebo (0.9% NaCl)Placebo: 1 ml of 0.9 % NaCl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabCanakinumab (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. | Drug | Study Intervention: Canakinumab |
| Placebo (0.9% NaCl)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. | Drug | Control Intervention: Placebo (0.9% NaCl) |
Primary outcome
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)
Health related quality of life (mental health; as assessed by the SF-36 mental health component score; MCS). The lower the score the more disability.
Change in Health related quality of life (physical health)
Time frame: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Health related quality of life (physical health; as assessed by the SF-36 physical component score; PCS). The lower the score the more disability.
Number of Hypoglycemic events
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Hypoglycemic events defined as glucose values below 3.0 mmol/l
11 secondary outcomes
Change in Postprandial Symptoms of hypoglycemia according to Edinburgh Hypoglycemia Scale (EHSS)
Time frame: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Change in Hypoglycemia unawareness (measured by modified Clarke Score)
Time frame: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Change in Fear of hypoglycemia (measured on a scale of 0 to 10)
Time frame: At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
Time below range (TBR; % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Pattern of sensor glucose
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Glycemic variability (defined as the coefficient of variation (CV) of sensor glucose)
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Mean amplitude of sensor glucose excursions (MAGE)
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Change in Body weight
Time frame: From Baseline (study day 1) to day 29 (-1 /+2 days)
Total adverse events
Time frame: From Baseline (study day 1) to Follow- up (day 90 +/- 11 days)
Serious adverse events
Time frame: From Baseline (study day 1) to Follow- up (day 90 +/- 11 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No. Results will be published in a relevant scientific journal and communicated to participants and relevant institutions through dissemination activities. Individual data are accessible on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Y Donath, Prof. Dr. principal investigator
University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canakinumab in people with Postprandial Hypoglycemia, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Y Donath, Prof. Dr. (+41 61 265 25 25, marc.donath@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.