Diabetes MellitusPhase 4NCT03877406
Effect of Empagliflozin on Body Composition and Ketones
A Phase 4 study testing Empagliflozin 10 MG and Hypoglycemics Oral in people with Diabetes Mellitus and Fat; Intolerance, Pancreas, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Fat; Intolerance, Pancreas
- What is being tested?
- Empagliflozin 10 MG and Hypoglycemics Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2018to 31 Dec 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45
Who cannot join
- Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI < 20 kg/m2 eGFR < 45 Malignancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Soo Lim, MD, PHD, 82-31-787-7035, limsoo@snu.ac.kr
Yujin Shin, MD, 82-31-787-6232, 54256@snubh.org
About this study
Official title: Decrease in Body Fat and Increase in Ketone Body After 6-month Treatment of Empagliflozin in Korean Patients With Type 2 Diabetes
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Read the detailed description
Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
- Conditions
- Diabetes Mellitus, Fat; Intolerance, Pancreas
- Being tested
- Empagliflozin 10 MG, Hypoglycemics Oral
- Keywords
- Sodium-glucose transporter 2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called SGLT2 inhibitor
addition of empagliflozin 10 MG
Hypoglycemics OralDrug
Also called Oral antidiabetic medication escalation
dose escalation of hypoglycemics oral
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | up-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor Receives: Drug: Hypoglycemics Oral |
| Study group | Experimental | addition of empagliflozin 10mg qd on standard oral antihyperglycemic agents Receives: Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
glycemic control
Measured: 6 months
Secondary outcomes (6)
Biochemical parameters
Ketone body concentration
Measured: 6 months
Body weight
Weight change
Measured: 6 months
Body fat
fat change
Measured: 6 months
Systolic and diastolic blood pressures
blood pressure change
Measured: 6 months
Lipid profile
Triglyceride
Measured: 6 months
Insulin resistance
HOMA-IR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Aug 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo N Lim, MD, PHD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877406
- Sponsor's protocol ID
- B-1507/307-007
- Status last verified
- Aug 2023
- First submitted
- 23 Oct 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease in Body Fat and Increase in Ketone Body After 6-month Treatment of Empagliflozin in Korean Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03877406
- Acronym / sponsor ID
- B-1507/307-007
- Conditions
- Diabetes Mellitus, Fat; Intolerance, Pancreas
- Keywords
- Sodium-glucose transporter 2 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Mar 2019 (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.
The purpose of this study is to evaluate changes of body composition induced by Sodium-glucose cotransporter-2 (SGLT2) inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Detailed description
Sodium-glucose cotransporter-2 (SGLT2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. However, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. The purpose of this study is to evaluate changes of body composition induced by SGLT2 inhibitor and its metabolic consequence in Korean type 2 diabetes (T2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Hypoglycemics Oralup-titration of standard medication including monotherapy or combination of Metformin, Sulfonylurea, DPP4 inhibitor |
| Study group | Experimental | Drug: Empagliflozin 10 MGaddition of empagliflozin 10mg qd on standard oral antihyperglycemic agents |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes Age: 20-79 years BMI ≥ 20 kg/m2 eGFR ≥ 45
Key exclusion criteria (1 listed)
- Patients with type 1 diabetes Secondary diabetes due to Cushing diseases, acromegaly Insulin user BMI < 20 kg/m2 eGFR < 45 Malignancy
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 10 MGAlso: SGLT2 inhibitoraddition of empagliflozin 10 MG | Drug | Study group |
| Hypoglycemics OralAlso: Oral antidiabetic medication escalationdose escalation of hypoglycemics oral | Drug | Control group |
Primary outcome
HbA1c
Time frame: 6 months
glycemic control
6 secondary outcomes
Biochemical parameters
Time frame: 6 months
Body weight
Time frame: 6 months
Body fat
Time frame: 6 months
Systolic and diastolic blood pressures
Time frame: 6 months
Lipid profile
Time frame: 6 months
Insulin resistance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Soo N Lim, MD, PHD principal investigator
Seoul National University Bundang Hospital
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 10 MG and Hypoglycemics Oral in people with Diabetes Mellitus and Fat; Intolerance, Pancreas, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujin N Shin, MD (82-31-787-7035 ext. 82317877035, 54256@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). 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 14 Aug 2023.