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Clinical trial

Empagliflozin and Anakinra for the Treatment of Postprandial Hypoglycemia in Patients With Prediabetes: a Randomized, Placebo-controlled Study

ID
Name
2020-01287; me20Donath
Description
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.
Trial arms
Trial start
2022-06-24
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
empagliflozin
Empagliflozin (Jardiance®; Boehringer Ingelheim (Schweiz) GmbH) is a highly selective, reversible inhibitor of the sodium glucose co-transporter 2 (SGLT2). Treatment consists of a single oral tablet of 25 mg of empagliflozin (Jardiance®) two hours before ingestion of the mixed-meal (Ensure plus® 375 ml, 75 g carbohydrates, 562 kcal, drinking time 5 minutes).
Arms:
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)
anakinra
Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra) in a 100 mg/0.67ml solution for SC injection. Treatment consists of a single subcutaneous injection of 100 mg Anakinra (Kineret®) three hours before ingestion of the mixed-meal (Ensure plus® 375 ml, 75 g carbohydrates, 562 kcal, drinking time 5 minutes).
Arms:
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)
saline subcutaneous (s.c.) (placebo)
Placebo for anakinra is 0.67 ml of sterile 0.9 % saline solution s. c. Treatment consists of a single subcutaneous injection of matched placebo (0.67 ml of 0.9 % saline) three hours before ingestion of the mixed-meal (Ensure plus® 375 ml, 75 g carbohydrates, 562 kcal, drinking time 5 minutes).
Arms:
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)
tablet per oral (p.o.) (placebo)
Placebo for empagliflozin is Winthrop P® (Zentiva, Frankfurt/Main) lactose tablet. Treatment consists of a single oral tablet of matched placebo two hours before ingestion of the mixed-meal (Ensure plus® 375 ml, 75 g carbohydrates, 562 kcal, drinking time 5 minutes).
Arms:
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)
Size
26
Primary endpoint
Number of symptomatic hypoglycemia
up to 3 hours after ingestion of the liquid mixed-meal
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Placebo controlled, double-blind, randomized, cross-over proof-of-concept study. Subjects will be randomized to either group 1-6 (ratio 1:1, in blocks of 4 participants).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants, investigators and study nurses will be blinded to the study drug.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}
Updated at
2024-02-20

1 organization

2 products

1 indication

Organization
University Hospital Basel
Product
empagliflozin
Indication
Postprandial Hypoglycemia
Product
anakinra