Endothelial FunctionPhase 4NCT02501616
Effect of Dapagliflozine on Systemic and Renal Endothelial Function
A Phase 4 study testing Metformin and Dapagliflozin in people with Endothelial Function and Type 2 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function. Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Endothelial Function, Type 2 Diabetes
- What is being tested?
- Metformin and Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- Treated with diet and exercise alone for recent 3 months
- Aged 20-80 years
- HbA1c 7~9%
- This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
- Are not breastfeeding.
- Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
- Intend not to become pregnant during the study.
Who cannot join
- Previous history of IHD or brain infarct
- Having typical anginal pain or atypical chest pain with dyspnea
- Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Boramae medical center
Seoul, 156-707
Bokyung Koo, bokyungkoomd@gmail.com
Min Kyong Moon
About this study
Official title: Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
This is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.
Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
- Conditions
- Endothelial Function, Type 2 Diabetes
- Being tested
- Metformin, Dapagliflozin
- Keywords
- SGLT2 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
DapagliflozinDrug
Also called Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Metformin first | Active comparator | Metformin first 8 wks --> Dapagliflozin 8wks.
Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day. Receives: Drug: Metformin; Drug: Dapagliflozin |
| Dapagliflozin first | Active comparator | Dapagliflozin first 8 wks --> Metformin 8wks.
Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed. Receives: Drug: Metformin; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive hyperemic index to measure endothelial function
endothelial function
Measured: 8 weeks
Secondary outcomes (3)
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
renal tubular injury
Measured: 8 week
Urine albumin excretion ratio
Urine albumin excretion
Measured: 8 week
Urine β2 microglobulin
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Kyong Moon, Seoul National University Hospital
- Investigators
- Min Kyong Moon, MD PhD, Principal investigator, Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501616
- Sponsor's protocol ID
- BRMH 26-2014-148
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
- ClinicalTrials.gov ID
- NCT02501616
- Acronym / sponsor ID
- BRMH 26-2014-148
- Conditions
- Endothelial Function, Type 2 Diabetes
- Keywords
- SGLT2 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- 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 is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function.
Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin first | Active comparator | Drug: Metformin, Drug: DapagliflozinMetformin first 8 wks --> Dapagliflozin 8wks. Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day. |
| Dapagliflozin first | Active comparator | Drug: Metformin, Drug: DapagliflozinDapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- Treated with diet and exercise alone for recent 3 months
- Aged 20-80 years
- HbA1c 7~9%
- This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
Key exclusion criteria (3 listed)
- Previous history of IHD or brain infarct
- Having typical anginal pain or atypical chest pain with dyspnea
- Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
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 |
|---|---|---|
| Metformin | Drug | Dapagliflozin first, Metformin first |
| DapagliflozinAlso: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor | Drug | Dapagliflozin first, Metformin first |
Primary outcome
Reactive hyperemic index to measure endothelial function
Time frame: 8 weeks
endothelial function
3 secondary outcomes
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
Time frame: 8 week
Urine albumin excretion ratio
Time frame: 8 week
Urine β2 microglobulin
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Min Kyong Moon, MD PhD principal investigator
Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
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 Metformin and Dapagliflozin in people with Endothelial Function and Type 2 Diabetes, run by Seoul National University 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 8 inclusion and 3 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 17 Jul 2015. 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 Min Kyong Moon, MD PhD (+82-2-870-2226, mkmoon@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive hyperemic index to measure endothelial function (time frame: 8 weeks). 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 17 Jul 2015.