Overview

Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes

Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to analyze whether the SGLT2-inhibitor empagliflozin or the IL-1 receptor antagonist anakinra may improve postprandial hypoglycemia in subjects with prediabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Treatments:
Empagliflozin
Interleukin 1 Receptor Antagonist Protein
Criteria
Inclusion Criteria:

- Subjects with prediabetes defined by Glycosylated haemoglobin A1c (HbA1c) 5.7-6.4 % or
fasting plasma glucose 6.1-6.9 mmol/l) or plasma glucose 2 h following 75 glucose
ingestion of 7.8-11.0 mmol/l.

- Hypoglycemia occuring 1 to 3 h following ingestion of a standardized liquid mixed-meal
(75 g carbohydrates) and fulfilling the Whipple's triad (glucose below 3.0 mmol/l).

- Age ≥ 18 years

- For subjects with reproductive potential, willingness to use contraceptive measures
adequate to prevent the subject from becoming pregnant during the study

Exclusion Criteria:

- Upper gastrointestinal surgery

- Diagnosis of any type of diabetes mellitus

- Signs of current infection

- Use of investigational drug up to one week prior to start of treatment phase

- Glucocorticoid therapy

- 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, aspartate
aminotransferase (AST)/ALT > 2 × ULN, alkaline phosphatase > 2 × ULN, or total
bilirubin [tBili] > 1.5 × ULN)

- Uncontrolled disease

- Currently pregnant or breastfeeding

- No subjects meeting the criteria for vulnerability

- Participation in another study with investigational drug within the 30 days preceding
and during the present study.