Empagliflozin for the Treatment of Postprandial Hypoglycemia

Last updated: August 13, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Terminated

Phase

3

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Treatment

Empagliflozin (Jardiance®;

Placebo Control Intervention

Clinical Study ID

NCT05036317
2021-00078; kt21Donath
  • Ages 18-75
  • All Genders

Study Summary

This randomized trial is to test whether a treatment with empagliflozin 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

  • 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 absolute neutrophil count (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: 40
Treatment Group(s): 2
Primary Treatment: Empagliflozin (Jardiance®;
Phase: 3
Study Start date:
March 11, 2022
Estimated Completion Date:
August 05, 2024

Study Description

Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. The prevalence of hypoglycemia in bariatric patients ranges from 0.5 % severe episodes up to 56 % and its symptoms range from asymptomatic to deleterious. This hypoglycemic condition is characterized by a rapid increase of plasma glucose after carbohydrate ingestion followed by an exaggerated hyperinsulinemic response. Hypoglycemia itself may lead to increased hunger, carbohydrate ingestion and following weight regain.

In a placebo-controlled, randomized, double-blind, crossover study, the SGLT2-inhibitor empagliflozin statistically significantly reduced the number of symptomatic hypoglycemia (2 vs. 7 symptomatic hypoglycemic episodes; p=0.013) compared to placebo after a mixed meal test in 12 patients after Roux-en-Y gastric bypass. Empagliflozin reduced the postprandial rise in glycemia and decreased subsequent insulin secretion, underlining the postulated mechanism of action.

This randomized trial is to test whether a treatment with empagliflozin 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.

Connect with a study center

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

    Basel, 4031
    Switzerland

    Site Not Available

  • University Hospital Berne and Center of Bariatric Surgery Berne

    Bern, 3010
    Switzerland

    Site Not Available

  • Cantonal Hospital Olten, Endocrine Outpatient Clinic

    Olten,
    Switzerland

    Site Not Available

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