Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes (Hypo-PrEA)
Postprandial Hypoglycemia
About this trial
This is an interventional treatment trial for Postprandial Hypoglycemia focused on measuring SGLT2-inhibitor empagliflozin, IL-1 receptor antagonist anakinra, prediabetes, insulin clearance, proinsulin
Eligibility 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.
Sites / Locations
- Department of Endocrinology, Diabetes and Metabolism, University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Other
Other
Other
Other
Other
Other
Group 1 (anakinra; placebo; empagliflozin)
Group 2 (placebo; anakinra; empagliflozin)
Group 3 (empagliflozin; placebo; anakinra)
Group 4 (empagliflozin; anakinra; placebo)
Group 5 (placebo; empagliflozin; anakinra)
Group 6 (anakinra; empagliflozin; placebo)
Group 1: study day 1: anakinra; study day2: placebo; study day 3: empagliflozin
study day 1: placebo; study day2: anakinra; study day 3: empagliflozin
study day 1: empagliflozin; study day2: placebo; study day 3: anakinra
study day 1: empagliflozin; study day2: anakinra; study day 3: placebo
study day 1: placebo; study day2: empagliflozin; study day 3: anakinra
study day 1:anakinra; study day2: empagliflozin; study day 3: placebo