ClinicalTrials.Veeva

Menu

Empagliflozin for the Treatment of Postprandial Hypoglycemia (EmpHy)

University Hospital Basel logo

University Hospital Basel

Status and phase

Terminated
Phase 3

Conditions

Postprandial Hypoglycemia

Treatments

Drug: Empagliflozin (Jardiance®;
Other: Placebo Control Intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05036317
2021-00078 kt21Donath;

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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
  • 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
  • Intolerance to the study drug
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Empagliflozin
Experimental group
Description:
Standard dose of empagliflozin (Jardiance®; Boehringer Ingelheim GmbH), i. e. 10 mg. Empagliflozin is an orally available inhibitor of SGLT2 and approved for the treatment of type 2 diabetes mellitus and will be given per os once daily in the morning for 28 days.
Treatment:
Drug: Empagliflozin (Jardiance®;
Placebo
Placebo Comparator group
Description:
Placebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days.
Treatment:
Other: Placebo Control Intervention

Trial contacts and locations

3

Loading...

Central trial contact

Matthias Hepprich, Dr. med.; Marc Y Donath, Prof. Dr. med.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems