Empagliflozin for the Treatment of Postprandial Hypoglycemia

NCT05036317 | Terminated Phase 3 DMC

• 1 other identifier: 2021-00078; kt21Donath
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Postprandial Hypoglycemia

Keywords

Empagliflozin; bariatric surgery; hyperinsulinemic response; SGLT2-inhibitor; insulin secretion; postbariatric hypoglycemia

Outcome Measures

Primary Outcomes (3)

• Change in Quality of life (mental health; as assessed by the SF-36 mental health component score; MCS)

  Change in Quality of life (mental health; as assessed by the SF-36 mental health component. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.

  at baseline, at day 29 and at day 60 (+/- 10 days) after baseline

• Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS)

  Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.

  at baseline, at day 29 and at day 60 (+/- 10 days) after baseline

• Hypoglycemic events defined as glucose values below 3.0 mmol/l

  Hypoglycemic events defined as glucose values below 3.0 mmol/l

  at 28 days after randomization

Secondary Outcomes (10)

• Postprandial Symptoms of hypoglycemia defined as acute onset of typical symptoms according to Edinburgh Hypoglycemia Scale along with a decreasing blood glucose level.

  at 28 days after randomization

• Hypoglycemia unawareness (measured by modified Clarke Score)

  at 28 days after randomization

• Fear of hypoglycemia (measured on a scale of 0 to 10)

  at 28 days after randomization

• Time below range (TBR): % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)

  at 28 days after randomization

• Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L

  at 28 days after randomization

Study Arms (2)

Empagliflozin

EXPERIMENTAL

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.

Drug: Empagliflozin (Jardiance®;

Placebo

PLACEBO COMPARATOR

Placebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days.

Other: Placebo Control Intervention

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.

Empagliflozin

Placebo Control Intervention OTHER

Placebo will be provided by Boehringer Ingelheim. It is identical to the interventional product apart from the active compound.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega- loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. \< 3.0 mmol/l and at least 5 hypoglycemic episodes per week despite dietary modification
• For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study
• Informed Consent as documented by signature

You may not qualify if:

• Any type of diabetes mellitus according to ADA criteria
• Intolerance to the study drug
• Signs of current infection
• Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (all remaining drugs have to be discontinued four half-life times before screening phase)
• 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, AST/ALT \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN)
• Uncontrolled congestive heart failure
• Uncontrolled malignant disease
• Currently pregnant or breastfeeding
• Known or suspected non-compliance, drug or alcohol abuse
• Meeting the criteria for vulnerability (e.g. participants incapable of judgment or participants under tutelage)
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• Participation in another clinical trial using investigational drugs in the last 30 days or planned participation in the next 60 days
• Previous enrolment into the current study,

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Boehringer Ingelheim: collaborator

Study Sites (3)

University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

University Hospital Berne and Center of Bariatric Surgery Berne

Bern, 3010, Switzerland

Location

Cantonal Hospital Olten, Endocrine Outpatient Clinic

Olten, Switzerland

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marc Y Donath, Prof. Dr. med.

  University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both subjects and investigators will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized, placebo-controlled, parallel-group double-blind superiority trial

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: March 11, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CH (3)