type1diabetesPhase 4NCT04917692
Empagliflozin in Adolescent Diabetes
A Phase 4 study testing Empagliflozin in people with type1diabetes, run by Ohio State University at 1 site in United States.
Trial summary
Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- type1diabetes
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Oct 2022
- Phase
- Phase 4
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 12-18 years
- Clinical diagnosis of type 1 diabetes
- Duration of diabetes > 1 r
- Multiple daily injections or continuous subcutaneous insulin infusion.
- Home glucose testing 4 times per day or continuous glucose monitor.
- Hemoglobin A1c levels will be ≤ 10.5%
- History of adherence to insulin administration, carbohydrate counting.
Who cannot join
- Duration of type 1 diabetes for less than 1 year
- Medical conditions other than type 1 diabetes or treated hypothyroidism
- Medications other than insulin, levothyroxine or oral contraceptives for birth control
- Antihypertensive medications, lipid lowering medications, or anti-hyperglycemic agents other than insulin.
- Acute viral and bacterial illnesses are not exclusionary, but we will take a health history at baseline and at the time of any study visit and if a recent illness has occurred we will delay testing until the individual is symptom free for 1 week and off and treatment for the illness.
- Hospital admission for diabetic ketoacidosis in the last year
Trial locations and contacts
1 site in 1 country.
About this study
Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1 diabetes empagliflozin improves endothelial function and vascular stiffness when used in conjunction with insulin. There is clear evidence that complications in type 1 diabetes have their origins during adolescents thus to reduce diabetic complications with adjunctive therapy, this age group must be studied. These studies will need to focus on the effects of these adjunctive agents on functional biomarkers for development of complications. This study is designed to develop pilot and feasibility data for a large scale trial of low dose empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal complications in adolescents between 12 and 18 years of age. The investigators will specifically study the effects of 8 weeks of empagliflozin on:
- Pre-and post-prandial inflammatory markers using high carbohydrate and high fat meals. Inflammatory markers to be measured include interleukin-6 (IL-6), tissue necrosing factor α (TNF-α), complement component C3 concentrations and skin advanced glycosylation endproducts (AGE).
- Pre-and post-prandial vascular function including forearm vascular resistance, endothelial function and pulse wave velocity.
- Microalbuminuria and pre- and post-prandial glomerular hyperfiltration, tubular injury and renal inflammation.
The investigators will, also, measure more traditional risk markers including blood pressure, hemoglobin A1c, and lipids. Eligible participants will have had diabetes for at least 1 year and not have other chronic medical illnesses or diabetes complications. Because of the risk of diabetic ketoacidosis (DKA) subjects must have a hemoglobin A1c level less than 9% and have no history of recurrent DKA or known insulin omission. This will be the first pilot study designed to explore primary endpoints regarding cardiovascular and renal disease rather than glucose control with empagliflozin therapy in adolescents with type 1 diabetes.
Read the detailed description
This is an 8 week single arm trial on the effects of empagliflozin 2.5 mg in adolescents with type 1 diabetes for at least 1 year. Subjects will be studied in the Clinical Research Center of the Wexner Medical Center at the Ohio State University 3 times. Visit 0 will be the initial study visit and will involve obtaining informed consent and assent, taking a medical history and performing a physical examination. Over the next 2 weeks the subjects will be contacted by the investigators to adjust insulin doses.
Visit 1 will be the baseline visit. It will occur at 8AM after an overnight fast. Blood samples will be collected to measure inflammatory markers will be collected and vascular function will be tested. Subjects will then be given premeal insulin and a breakfast. Following this, additional blood samples and vascular function measurements will be taken at 30, 60, 90, and 120 minutes.
After completion of the tests home insulin doses will be reduced and the subjects will be given empagliflozin 2.5 mg daily to take at home for the next 8 weeks. They will be instructed regarding potential side effects including diabetic ketoacidosis and genital infections.
Subjects will be contacted regularly by the investigators during these 8 weeks to review home glucose monitoring and potential side effects. After completion of the 8 weeks Visit 2 will occur which will be identical Visit 1.
- Conditions
- type1diabetes
- Being tested
- Empagliflozin
- Keywords
- type 1 diabetes, adolescents, cardiovascular risk, inflammation, complement, endothelial function, empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 1, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
2.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin | Experimental | empagliflozin 2.5 mg daily Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin 6
IL6 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Measured: 8 weeks
Glomerular filtration rate
Cystatin C levels will be used to calculate GFR before and after high carbohydrate meal at the beginning and end of the 8 weeks
Measured: 8 weeks
Endothelial function
Percentage change in forearm vascular resistance following 5 min of arterial occlusion.
Measured: 8 weeks
Number of episodes of diabetic ketoacidosis per patient
Frequency of diabetic ketoacidosis will be assessed through the 8 weeks
Measured: 8 weeks
Secondary outcomes (4)
Complement
Complement component C3 and C4 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Measured: 8 weeks
Lipids
Lipid levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Measured: 8 weeks
Pulse wave velocity
Pulse wave velocity will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Measured: 8 weeks
Number of episodes of hypoglycemia per patient
Frequency of hypoglycemia will be assessed over 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label intervention study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Diacomp
- Responsible party
- Principal investigator, Robert Hoffman, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917692
- Sponsor's protocol ID
- Empad
- Status last verified
- Mar 2023
- First submitted
- 14 May 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin in Adolescent Diabetes
- ClinicalTrials.gov ID
- NCT04917692
- Acronym / sponsor ID
- Empad
- Conditions
- type1diabetes
- Keywords
- type 1 diabetes, adolescents, cardiovascular risk, inflammation, complement, endothelial function, empagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Diacomp
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Jun 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.
Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1 diabetes empagliflozin improves endothelial function and vascular stiffness when used in conjunction with insulin. There is clear evidence that complications in type 1 diabetes have their origins during adolescents thus to reduce diabetic complications with adjunctive therapy, this age group must be studied. These studies will need to focus on the effects of these adjunctive agents on functional biomarkers for development of complications. This study is designed to develop pilot and feasibility data for a large scale trial of low dose empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal complications in adolescents between 12 and 18 years of age. The investigators will specifically study the effects of 8 weeks of empagliflozin on:
- Pre-and post-prandial inflammatory markers using high carbohydrate and high fat meals. Inflammatory markers to be measured include interleukin-6 (IL-6), tissue necrosing factor α (TNF-α), complement component C3 concentrations and skin advanced glycosylation endproducts (AGE).
- Pre-and post-prandial vascular function including forearm vascular resistance, endothelial function and pulse wave velocity.
- Microalbuminuria and pre- and post-prandial glomerular hyperfiltration, tubular injury and renal inflammation.
The investigators will, also, measure more traditional risk markers including blood pressure, hemoglobin A1c, and lipids. Eligible participants will have had diabetes for at least 1 year and not have other chronic medical illnesses or diabetes complications. Because of the risk of diabetic ketoacidosis (DKA) subjects must have a hemoglobin A1c level less than 9% and have no history of recurrent DKA or known insulin omission. This will be the first pilot study designed to explore primary endpoints regarding cardiovascular and renal disease rather than glucose control with empagliflozin therapy in adolescents with type 1 diabetes.
Detailed description
This is an 8 week single arm trial on the effects of empagliflozin 2.5 mg in adolescents with type 1 diabetes for at least 1 year. Subjects will be studied in the Clinical Research Center of the Wexner Medical Center at the Ohio State University 3 times. Visit 0 will be the initial study visit and will involve obtaining informed consent and assent, taking a medical history and performing a physical examination. Over the next 2 weeks the subjects will be contacted by the investigators to adjust insulin doses.
Visit 1 will be the baseline visit. It will occur at 8AM after an overnight fast. Blood samples will be collected to measure inflammatory markers will be collected and vascular function will be tested. Subjects will then be given premeal insulin and a breakfast. Following this, additional blood samples and vascular function measurements will be taken at 30, 60, 90, and 120 minutes.
After completion of the tests home insulin doses will be reduced and the subjects will be given empagliflozin 2.5 mg daily to take at home for the next 8 weeks. They will be instructed regarding potential side effects including diabetic ketoacidosis and genital infections.
Subjects will be contacted regularly by the investigators during these 8 weeks to review home glucose monitoring and potential side effects. After completion of the 8 weeks Visit 2 will occur which will be identical Visit 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label intervention study
| Arm | Type | Receives |
|---|---|---|
| empagliflozin | Experimental | Drug: Empagliflozinempagliflozin 2.5 mg daily |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 12-18 years
- Clinical diagnosis of type 1 diabetes
- Duration of diabetes > 1 r
- Multiple daily injections or continuous subcutaneous insulin infusion.
- Home glucose testing 4 times per day or continuous glucose monitor.
Key exclusion criteria (6 listed)
- Duration of type 1 diabetes for less than 1 year
- Medical conditions other than type 1 diabetes or treated hypothyroidism
- Medications other than insulin, levothyroxine or oral contraceptives for birth control
- Antihypertensive medications, lipid lowering medications, or anti-hyperglycemic agents other than insulin.
- Acute viral and bacterial illnesses are not exclusionary, but we will take a health history at baseline and at the time of any study visit and if a recent illness has occurred we will delay testing until the individual is symptom free for 1 week and off and treatment for the illness.
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 |
|---|---|---|
| EmpagliflozinAlso: Jardiance2.5 mg daily | Drug | empagliflozin |
Primary outcome
Interleukin 6
Time frame: 8 weeks
IL6 levels will be measured before and after high carbohydrate meal at the beginning and end of the 8 weeks
Glomerular filtration rate
Time frame: 8 weeks
Cystatin C levels will be used to calculate GFR before and after high carbohydrate meal at the beginning and end of the 8 weeks
Endothelial function
Time frame: 8 weeks
Percentage change in forearm vascular resistance following 5 min of arterial occlusion.
Number of episodes of diabetic ketoacidosis per patient
Time frame: 8 weeks
Frequency of diabetic ketoacidosis will be assessed through the 8 weeks
4 secondary outcomes
Complement
Time frame: 8 weeks
Lipids
Time frame: 8 weeks
Pulse wave velocity
Time frame: 8 weeks
Number of episodes of hypoglycemia per patient
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with type1diabetes, run by Ohio State University at 1 site in United States.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
Interleukin 6 (time frame: 8 weeks). The study lists 4 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 23 Mar 2023.