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

Conditions

• Postprandial Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• empagliflozin — DRUG
  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).
• anakinra — DRUG
  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).
• saline subcutaneous (s.c.) (placebo) — OTHER
  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).
• tablet per oral (p.o.) (placebo) — OTHER
  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).

Study Details

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.

Key Dates

Start date

Jun 24, 2022

Status verified

Feb 2026

Primary completion

May 1, 2026

Completion

May 1, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Other: Group 1 (anakinra; placebo; empagliflozin)
  Group 1: study day 1: anakinra; study day2: placebo; study day 3: empagliflozin
• Other: Group 2 (placebo; anakinra; empagliflozin)
  study day 1: placebo; study day2: anakinra; study day 3: empagliflozin
• Other: Group 3 (empagliflozin; placebo; anakinra)
  study day 1: empagliflozin; study day2: placebo; study day 3: anakinra
• Other: Group 4 (empagliflozin; anakinra; placebo)
  study day 1: empagliflozin; study day2: anakinra; study day 3: placebo
• Other: Group 5 (placebo; empagliflozin; anakinra)
  study day 1: placebo; study day2: empagliflozin; study day 3: anakinra
• Other: Group 6 (anakinra; empagliflozin; placebo)
  study day 1:anakinra; study day2: empagliflozin; study day 3: placebo

Primary Outcome Measure

Number of symptomatic hypoglycemia [ Time Frame: up to 3 hours after ingestion of the liquid mixed-meal ]