Diabetes Mellitus, Type 2Phase 4BEYONDNCT02564926
Foxiga Korea Local Phase 4 Study
A Phase 4 study testing Dapagliflozin and Glimepiride in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 14 sites in South Korea.
Trial summary
To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 5 Jan 2016to 15 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
- Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
- Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
- Written informed consent
- WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- WOCBP must have a negative urine pregnancy test at screening visit WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
Who cannot join
- Type 1 diabetes or history of diabetic ketoacidosis
- Pregnant or breast-feeding patients
- eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
- Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
- Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
- Bariatric surgery within 2 years; treatment of anti-obesity drugs 3 months prior to randomization; any treatment leading to unstable body weight. (Unstable body weight is considered reliable in the judgment of the Investigator.)
Show all 10Show fewer
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
- History of alcohol or drug abuse judged by physician within 3 months prior to randomization
- Concomitant participation in any other clinical study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Research Site
Ansan-si, 15355
Research Site
Changwon-si, 51353
Research Site
Daegu, 41931
Research Site
Daejeon, 35233
Research Site
Goyang-si, 10326
Research Site
Incheon, 21565
Research Site
Seongnam-si, 13620
Research Site
Seoul, 01830
Research Site
Seoul, 04401
Research Site
Seoul, 05278
Research Site
Seoul, 06273
Research Site
Suwon, 16499
Research Site
Uijeongbu-si, 11765
Research Site
Wŏnju, 220-701
About this study
Official title: Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.
Read the detailed description
This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.
Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg.
Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, Glimepiride
- Keywords
- DM
- 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.
DapagliflozinDrug
Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
GlimepirideDrug
Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg + Metformin 1000mg Receives: Drug: Dapagliflozin |
| Glimepiride | Active comparator | Glimepiriide 1-2mg + Metformin 1000mg Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Measured: From baseline to Week 52
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Measured: From baseline to Week 52
Secondary outcomes (14)
Adjusted Mean Change in HbA1c at Week 52
Adjusted Mean Change in HbA1c at Week 52
Measured: From baseline to Week 52
HbA1c <7.0% at Week 52
HbA1c <7.0% at Week 52
Measured: 52 weeks
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Total Body Weight at Week 52
Adjusted Mean Change in Total Body Weight at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Waist Circumference at Week 52
Adjusted Mean Change in Waist Circumference at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Lean Body Mass at Week 52
Adjusted Mean Change in Lean Body Mass at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in Adinopectin at Week 52
Adjusted Mean Change in Adinopectin at Week 52
Measured: From baseline to Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Measured: From baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start5 Jan 2016
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564926
- Sponsor's protocol ID
- D1690L00067
- Acronym
- BEYOND
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2015
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
- ClinicalTrials.gov ID
- NCT02564926
- Acronym / sponsor ID
- BEYOND / D1690L00067
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month, randomised, open-label, parallel-group, multi-centre phase IV study.
Detailed description
This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.
Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1~2 mgqd in an open-label manner for 12 months as add-on to metformin 1000 mg.
Parallel group study design was chosen. In order maintain the practicality of the phase IV study, open label design of study drug delivery was chosen. The reading of the DXA scans will be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin 10mg + Metformin 1000mg |
| Glimepiride | Active comparator | Drug: GlimepirideGlimepiriide 1-2mg + Metformin 1000mg |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults with T2DM (Male or female, ≥ 19 and ≤ 75 yrs)
- Patients in insufficient glycemic control (HbA1c > 7.5% and < 9.5% in recent 4 weeks)
- Patients with an unchanged dose of metformin (≥ 1,000 mg/day) for > 8 weeks prior to randomization
- Written informed consent
- WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
Key exclusion criteria (10 listed)
- Type 1 diabetes or history of diabetic ketoacidosis
- Pregnant or breast-feeding patients
- eGFR < 60 mL/min/1.73 m2 (MDRD) on visit 1.
- Indication of active liver disease (AST/ALT/total bilirubin > 3 X upper limits of normal) on visit 1.
- Acute coronary syndrome, stroke or TIA within 3 months prior to randomization
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 |
|---|---|---|
| DapagliflozinSubject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment | Drug | Dapagliflozin |
| GlimepirideSubject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment | Drug | Glimepiride |
Primary outcome
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
Time frame: From baseline to Week 52
Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
Time frame: From baseline to Week 52
Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment
14 secondary outcomes
Adjusted Mean Change in HbA1c at Week 52
Time frame: From baseline to Week 52
HbA1c <7.0% at Week 52
Time frame: 52 weeks
Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Total Body Weight at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Waist Circumference at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Body Mass Index (BMI) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Lean Body Mass at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in Adinopectin at Week 52
Time frame: From baseline to Week 52
Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
Time frame: From baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D1690l00067\_CSP\_RedactedLink provided by the sponsor.
- D1690l00067\_SAP\_RedactedLink provided by the sponsor.
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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.
14 sites 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 Glimepiride in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 14 sites 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 7 inclusion and 10 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan (time frame: From baseline to Week 52). The study lists 2 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 20 Aug 2019.