Empagliflozin for the Treatment of Postprandial Hypoglycemia

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

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 dietary modification

• Age ≥ 18 years

• For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study

• Informed Consent as documented by signature

Exclusion Criteria:

• Any type of diabetes mellitus according to ADA criteria

• Signs of current infection

• 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 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 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