Postprandial HypoglycemiaPhase 3EmpHyNCT05036317
Empagliflozin for the Treatment of Postprandial Hypoglycemia
A Phase 3 study testing Empagliflozin (Jardiance®; in people with Postprandial Hypoglycemia, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postprandial Hypoglycemia
- What is being tested?
- Empagliflozin (Jardiance®;
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 11 Mar 2022to 5 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
Basel, 4031
University Hospital Berne and Center of Bariatric Surgery Berne
Bern, 3010
Cantonal Hospital Olten, Endocrine Outpatient Clinic
Olten
About this study
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.
Read the detailed description
Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. The prevalence of hypoglycemia in bariatric patients ranges from 0.5 % severe episodes up to 56 % and its symptoms range from asymptomatic to deleterious. This hypoglycemic condition is characterized by a rapid increase of plasma glucose after carbohydrate ingestion followed by an exaggerated hyperinsulinemic response. Hypoglycemia itself may lead to increased hunger, carbohydrate ingestion and following weight regain.
In a placebo-controlled, randomized, double-blind, crossover study, the SGLT2-inhibitor empagliflozin statistically significantly reduced the number of symptomatic hypoglycemia (2 vs. 7 symptomatic hypoglycemic episodes; p=0.013) compared to placebo after a mixed meal test in 12 patients after Roux-en-Y gastric bypass. Empagliflozin reduced the postprandial rise in glycemia and decreased subsequent insulin secretion, underlining the postulated mechanism of action.
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
- Being tested
- Empagliflozin (Jardiance®;, Placebo Control Intervention
- Keywords
- Empagliflozin, bariatric surgery, hyperinsulinemic response, SGLT2-inhibitor, insulin secretion, postbariatric hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 InterventionOther
Placebo will be provided by Boehringer Ingelheim. It is identical to the interventional product apart from the active compound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Empagliflozin (Jardiance®; |
| Placebo | Placebo comparator | Placebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days. Receives: Other: Placebo Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Postprandial Symptoms of hypoglycemia defined as acute onset of typical symptoms according to Edinburgh Hypoglycemia Scale (7-point Likert scale (1 = not present, 7 = very intense)) along with a decreasing blood glucose level. The postprandial period is defined as 3 hours following meal intake.
Measured: at 28 days after randomization
Hypoglycemia unawareness (measured by modified Clarke Score)
Hypoglycemia unawareness (measured by modified Clarke Score). The Clarke method comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to, hypoglycemia. A score of four or more implies impaired awareness of hypoglycemia.
Measured: at 28 days after randomization
Fear of hypoglycemia (measured on a scale of 0 to 10)
Fear of hypoglycemia (measured on a scale of 0 to 10)
Measured: at 28 days after randomization
Time below range (TBR): % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Time below range (TBR): % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Measured: at 28 days after randomization
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Measured: at 28 days after randomization
Pattern of sensor glucose
Pattern of sensor glucose, defined as the slope of postprandial increase (calculated as the maximal rate of increase observed over 20min in the postprandial period) and decrease (calculated as the maximal rate of decrease over 20min in the postprandial period).
Measured: at 28 days after randomization
Glycemic variability
Glycemic variability (defined as the coefficient of variation (CV) of sensor glucose)
Measured: at 28 days after randomization
Mean amplitude of sensor glucose excursions (MAGE)
Mean amplitude of sensor glucose excursions (MAGE)
Measured: at 28 days after randomization
Total number of adverse events
Total number of adverse events
Measured: up to 60 days after randomization
Number of Serious adverse events
Number of Serious adverse events
Measured: up to 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start11 Mar 2022
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Why it stopped: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized, placebo-controlled, parallel-group double-blind superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Marc Y Donath, Prof. Dr. med., Principal investigator, University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036317
- Sponsor's protocol ID
- 2021-00078; kt21Donath
- Acronym
- EmpHy
- Status last verified
- Aug 2024
- First submitted
- 1 Sep 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin for the Treatment of Postprandial Hypoglycemia
- ClinicalTrials.gov ID
- NCT05036317
- Acronym / sponsor ID
- EmpHy / 2021-00078; kt21Donath
- Conditions
- Postprandial Hypoglycemia
- Keywords
- Empagliflozin, bariatric surgery, hyperinsulinemic response, SGLT2-inhibitor, insulin secretion, postbariatric hypoglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postprandial hypoglycemia is a debilitating medical complication after bariatric surgery for which no approved pharmacological treatment exists. The prevalence of hypoglycemia in bariatric patients ranges from 0.5 % severe episodes up to 56 % and its symptoms range from asymptomatic to deleterious. This hypoglycemic condition is characterized by a rapid increase of plasma glucose after carbohydrate ingestion followed by an exaggerated hyperinsulinemic response. Hypoglycemia itself may lead to increased hunger, carbohydrate ingestion and following weight regain.
In a placebo-controlled, randomized, double-blind, crossover study, the SGLT2-inhibitor empagliflozin statistically significantly reduced the number of symptomatic hypoglycemia (2 vs. 7 symptomatic hypoglycemic episodes; p=0.013) compared to placebo after a mixed meal test in 12 patients after Roux-en-Y gastric bypass. Empagliflozin reduced the postprandial rise in glycemia and decreased subsequent insulin secretion, underlining the postulated mechanism of action.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 randomized, placebo-controlled, parallel-group double-blind superiority trial
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin (Jardiance®;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 | Placebo comparator | Other: Placebo Control InterventionPlacebo provided by Boehringer Ingelheim Switzerland. Per os once daily in the morning for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin (Jardiance®;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. | Drug | Empagliflozin |
| Placebo Control InterventionPlacebo will be provided by Boehringer Ingelheim. It is identical to the interventional product apart from the active compound. | Other | Placebo |
Primary outcome
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
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.
Change in Quality of life (physical health; as assessed by the SF-36 mental physical component score; PCS)
Time frame: 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). 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.
Hypoglycemic events defined as glucose values below 3.0 mmol/l
Time frame: at 28 days after randomization
Hypoglycemic events defined as glucose values below 3.0 mmol/l
10 secondary outcomes
Postprandial Symptoms of hypoglycemia defined as acute onset of typical symptoms according to Edinburgh Hypoglycemia Scale along with a decreasing blood glucose level.
Time frame: at 28 days after randomization
Hypoglycemia unawareness (measured by modified Clarke Score)
Time frame: at 28 days after randomization
Fear of hypoglycemia (measured on a scale of 0 to 10)
Time frame: at 28 days after randomization
Time below range (TBR): % of sensor glucose readings and time between 3.0 and 3.8 mmol/L)
Time frame: at 28 days after randomization
Time in hypoglycemia: % of sensor glucose readings and time below 3.0 mmol/L
Time frame: at 28 days after randomization
Pattern of sensor glucose
Time frame: at 28 days after randomization
Glycemic variability
Time frame: at 28 days after randomization
Mean amplitude of sensor glucose excursions (MAGE)
Time frame: at 28 days after randomization
Total number of adverse events
Time frame: up to 60 days after randomization
Number of Serious adverse events
Time frame: up to 60 days after randomization
Results and safety
The study was stopped early (reason given: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Y Donath, Prof. Dr. med. principal investigator
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin (Jardiance®; in people with Postprandial Hypoglycemia, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.