Empagliflozin for the Treatment of Postprandial Hypoglycemia

Conditions

• Postprandial Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin (Jardiance®; — DRUG
  Each tablet contains the active substance of 10 mg empagliflozin as well as the adjuvant lactose-monohydrate and is taken orally once daily in the morning.
• Placebo Control Intervention — OTHER
  Placebo will be provided by Boehringer Ingelheim. It is identical to the interventional product apart from the active compound.

Study Details

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.

Key Dates

Start date

Mar 11, 2022

Status verified

Aug 2024

Primary completion

Aug 5, 2024

Completion

Aug 5, 2024

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Empagliflozin
  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.
• Placebo Comparator: Placebo
  Placebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days.

Primary Outcome Measure

Change in Quality of life (mental health; as assessed by the SF-36 mental health component score; MCS) [ Time Frame: at baseline, at day 29 and at day 60 (+/- 10 days) after baseline ]