Health TrialsbyHealthPanel

Canakinumab for the Treatment of Postprandial Hypoglycemia

ConditionPostprandial Hypoglycemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any type of diabetes mellitus according to ADA criteria

Intolerance to the study drug

Signs of current infection

Any use of immunosuppressive medication

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Study Intervention: CanakinumabActive comparator 1 intervention
Group B: Control Intervention: Placebo (0.9% NaCl)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
2

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.

Time frame
At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
3

Number of Hypoglycemic events

Hypoglycemic events defined as glucose values below 3.0 mmol/l

Time frame
From Baseline (study day 1) to day 29 (-1 /+2 days)

Secondary outcomes

1

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.

Time frame
At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
2

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

Time frame
At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
3

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"

Time frame
At Baseline (study day 1), day 29 (-1 /+2 days) and at Follow- up (day 90 +/- 11 days)
4

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)

Time frame
From Baseline (study day 1) to day 29 (-1 /+2 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
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