DiabetesPhase 4NCT02610088
Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
A Phase 4 study testing Dapagliflozin and Gliclazide in people with Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Dapagliflozin and Gliclazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Sep 2018
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with HbA1c ≥ 7.5% at screening visit
- Male or female between 40 and 70 years of age
- Patients taking metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
- BMI ≥23 kg/m²
- Estimated GFR ≥ 60 ml/min/1.73m²
Who cannot join
- Patients with acute coronary syndrome within 3 months prior to screening visit
- Pregnant or breast feeding women or reproductive-age women who refuse contraception
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
- Other clinical trial within 30 days
- Alcohol abuse
- Contraindication to SGLT2 inhibitors or sulfonylurea
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes
Read the detailed description
Obesity, and especially visceral/abdominal adiposity, is associated with diabetes and increased cardiovascular risk. In previous randomized, double-blind, placebo-controlled study, dapagliflozin reduced total body weight, predominantly by reducing fat mass, visceral adipose tissue and sc adipose tissue in type 2 diabetes. This study supported that caloric loss from glycosuria, and not fluid loss, was principally responsible for decrease in total body weight and fat mass. In fact, there have been several reports proving that inhibition of SGLT2 improves β-cell function and reduces body weight and blood pressure. However, effects of SGLT2 inhibitors on lipid profiles have not been decided yet in patients with type 2 diabetes. Furthermore, there are few data to demonstrate the effects of SGLT2 inhibitors on CV risk.
Many systems and pathways are involved in development of atherosclerosis in the arterial wall. Accumulating evidence suggests that endothelial dysfunction plays an important role particularly in the first stage of atherogenesis in patients with diabetes. Approaches designed to improve endothelial function may therefore have additional therapeutic value in the prevention and treatment of atherosclerotic disease. Endothelial dysfunction is related to decreased production and bioavailability of nitric oxide (NO). Endothelial function was measured through several circulating biomarker such as NO, endothelin-1 or non-invasive techniques such as flow-mediated dilation (FMD), skin laser doppler. Among them, FMD is known to as the optimal tool. In addition, several noninvasive techniques including measurement of the ankle-brachial index (ABI), carotid intima-media thickness (IMT) and pulse wave velocity (PWV) have been used for evaluation of atherosclerosis.
If a participant's HbA1c dose not decreas by >0.4% at 12 weeks, rescue therapy can be added at the investigator's discretion.
- Conditions
- Diabetes
- Being tested
- Dapagliflozin, Gliclazide
- Keywords
- Diabetes, Atherosclerosis, Cardiovascular disease, Endothelial dysfunction, Vascular function, Dapagliflozin, Gliclazide
- Medical subject headings
- Diabetes Mellitus, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion.
GliclazideDrug
Also called Diamicron MR
Gliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | Dapagliflozin will be started in patient with type 2 diabetes mellitus Receives: Drug: Dapagliflozin |
| Gliclazide | Active comparator | Gliclazide will be started in patient with type 2 diabetes mellitus Receives: Drug: Gliclazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function assessed by Flow-mediated vasodilation (FMD)
The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow (causing shear-stress) during reactive hyperaemia (induced by cuff inflation and then deflation). This leads to endothelium-dependent dilatation; the response is contrasted with that to sublingual nitroglycerin, an endothelium-independent dilator. The artery is scanned and the diameter measured during three conditions; at baseline, during reactive hyperaemia (induced by inflation and then deflation of a sphygmomanometer cuff around the limb, distal to the scanned part of the artery) and finally after administration of sublingual nitroglycerin (which causes endothelium-independent smooth muscle mediated vasodilatation).
Measured: 24weeks
Secondary outcomes (9)
Change of blood pressure
Measured: 24weeks
Lipid metabolism assessed by triglyceride, low density lipoprotein-cholesterol and high density lipoprotein-cholesterol
Measured: 24weeks
Inflammatory markers assessed by hsCRP
Measured: 24weeks
Change of body composition assessed by bioelectrical impedance analysis (BIA) methods
Measured: 24weeks
Glucose metabolism assessed by glycated hemoglobin and fasting plasma glucose
Measured: 24weeks
Microcirculation assessed by laser doppler
Measured: 24weeks
Vascular health assessment by pulse wave velocity (PWV)
PWV, by definition, is the distance traveled (Delta x) by the wave divided by the time (Delta t) for the wave to travel that distance
Measured: 24weeks
Vascular health assessment by Ankle-brachial index (ABI)
The ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).
Measured: 24weeks
Carotid intima-media thickness (cIMT) assessed by ultrasound
Intima-media thickness (IMT), also called intimal medial thickness, is a measurement of the thickness of tunica intima and tunica media, the innermost two layers of the wall of an artery.
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610088
- Sponsor's protocol ID
- B-1507/307-006
- Status last verified
- Sep 2018
- First submitted
- 15 Nov 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide
- ClinicalTrials.gov ID
- NCT02610088
- Acronym / sponsor ID
- B-1507/307-006
- Conditions
- Diabetes
- Keywords
- Diabetes, Atherosclerosis, Cardiovascular disease, Endothelial dysfunction, Vascular function, Dapagliflozin, Gliclazide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 20 Nov 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.
The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes
Detailed description
Obesity, and especially visceral/abdominal adiposity, is associated with diabetes and increased cardiovascular risk. In previous randomized, double-blind, placebo-controlled study, dapagliflozin reduced total body weight, predominantly by reducing fat mass, visceral adipose tissue and sc adipose tissue in type 2 diabetes. This study supported that caloric loss from glycosuria, and not fluid loss, was principally responsible for decrease in total body weight and fat mass. In fact, there have been several reports proving that inhibition of SGLT2 improves β-cell function and reduces body weight and blood pressure. However, effects of SGLT2 inhibitors on lipid profiles have not been decided yet in patients with type 2 diabetes. Furthermore, there are few data to demonstrate the effects of SGLT2 inhibitors on CV risk.
Many systems and pathways are involved in development of atherosclerosis in the arterial wall. Accumulating evidence suggests that endothelial dysfunction plays an important role particularly in the first stage of atherogenesis in patients with diabetes. Approaches designed to improve endothelial function may therefore have additional therapeutic value in the prevention and treatment of atherosclerotic disease. Endothelial dysfunction is related to decreased production and bioavailability of nitric oxide (NO). Endothelial function was measured through several circulating biomarker such as NO, endothelin-1 or non-invasive techniques such as flow-mediated dilation (FMD), skin laser doppler. Among them, FMD is known to as the optimal tool. In addition, several noninvasive techniques including measurement of the ankle-brachial index (ABI), carotid intima-media thickness (IMT) and pulse wave velocity (PWV) have been used for evaluation of atherosclerosis.
If a participant's HbA1c dose not decreas by >0.4% at 12 weeks, rescue therapy can be added at the investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: DapagliflozinDapagliflozin will be started in patient with type 2 diabetes mellitus |
| Gliclazide | Active comparator | Drug: GliclazideGliclazide will be started in patient with type 2 diabetes mellitus |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes with HbA1c ≥ 7.5% at screening visit
- Male or female between 40 and 70 years of age
- Patients taking metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
- BMI ≥23 kg/m²
- Estimated GFR ≥ 60 ml/min/1.73m²
Key exclusion criteria (8 listed)
- Patients with acute coronary syndrome within 3 months prior to screening visit
- Pregnant or breast feeding women or reproductive-age women who refuse contraception
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
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 |
|---|---|---|
| DapagliflozinAlso: ForxigaDapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion. | Drug | Dapagliflozin |
| GliclazideAlso: Diamicron MRGliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion. | Drug | Gliclazide |
Primary outcome
Vascular function assessed by Flow-mediated vasodilation (FMD)
Time frame: 24weeks
The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow (causing shear-stress) during reactive hyperaemia (induced by cuff inflation and then deflation). This leads to endothelium-dependent dilatation; the response is contrasted with that to sublingual nitroglycerin, an endothelium-independent dilator. The artery is scanned and the diameter measured during three conditions; at baseline, during reactive hyperaemia (induced by inflation and then deflation of a sphygmomanometer cuff around the limb, distal to the scanned part of the artery) and finally after administration of sublingual nitroglycerin (which causes endothelium-independent smooth muscle mediated vasodilatation).
9 secondary outcomes
Change of blood pressure
Time frame: 24weeks
Lipid metabolism assessed by triglyceride, low density lipoprotein-cholesterol and high density lipoprotein-cholesterol
Time frame: 24weeks
Inflammatory markers assessed by hsCRP
Time frame: 24weeks
Change of body composition assessed by bioelectrical impedance analysis (BIA) methods
Time frame: 24weeks
Glucose metabolism assessed by glycated hemoglobin and fasting plasma glucose
Time frame: 24weeks
Microcirculation assessed by laser doppler
Time frame: 24weeks
Vascular health assessment by pulse wave velocity (PWV)
Time frame: 24weeks
Vascular health assessment by Ankle-brachial index (ABI)
Time frame: 24weeks
Carotid intima-media thickness (cIMT) assessed by ultrasound
Time frame: 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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 Dapagliflozin and Gliclazide in people with Diabetes, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 11 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vascular function assessed by Flow-mediated vasodilation (FMD) (time frame: 24weeks). 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 11 Sep 2018.