Diabetes Mellitus, Type 2Phase 4NCT04653779
A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg
A Phase 4 study testing Evogliptin 5mg/Metformin 1000mg in people with Diabetes Mellitus, Type 2 and Renal Disease, run by Dong-A ST Co., Ltd. at 2 sites in South Korea.
Trial summary
Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Renal Disease, Diabetes Mellitus
- What is being tested?
- Evogliptin 5mg/Metformin 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2020to Jul 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥60 years
- Subjects with type 2 diabetes mellitus
- Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
- Subjects with HbA1c≤7.5% at screening
- Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
- Subjects with fasting glucose≤200 at screening
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
Who cannot join
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- ESRD or Patients who have kidney dialysis
- Subjects with ALT and AST 3 times or higher than upper normal range
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Suncheonhyang Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
Suncheonhyang Bucheon Hospital, 82-32-621-6363, irb@schmc.ac.kr
Bo Yeon Kim, MD
Se-jong hospital
Bucheon-si, Gyeonggi-do, 14754
Se-jong hospital, 82-32-340-1236
Chong Hwa Kim, MD
About this study
Official title: A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases
Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases
- Conditions
- Diabetes Mellitus, Type 2, Renal Disease, Diabetes Mellitus, Metabolic Disease, Endocrine System Diseases
- Being tested
- Evogliptin 5mg/Metformin 1000mg
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Diseases, Diabetes Mellitus, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evogliptin 5mg/Metformin 1000mgDrug
Also called SUGAMET®XR tablet 5/1000mg
Size reduction of a tablet formulation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients receive Evogliptin 5mg/Metformin 1000mg once a day Receives: Drug: Evogliptin 5mg/Metformin 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The preference regarding convenience of medication
Looking back on the experience of participating in the study, which would you prefer, any of the existing DPP-4 inhibitor/metformin 1000mg sustained-release combination drug or the SugarMet® sustained-release tablet 5/1000mg?
Measured: 12 weeks
Secondary outcomes (9)
Change from baseline in HbA1c (%) After 12 weeks
Measured: 12 weeks
Change from baseline in HbA1C response rate(%) After 12 weeks
Measured: 12 weeks
Change from baseline in Glycated albumin After 12 weeks
Measured: 12 weeks
Change from baseline in e-GFR After 12 weeks
Measured: 12 weeks
Change from baseline in UACR After 12 weeks
Urine Albumin-to-Creatinin Ratio
Measured: 12 weeks
Change from baseline in HbA1c (%) After 12 weeks NAG
N-Acetyl-Glucosaminidase
Measured: 12 weeks
Change from baseline in Nephrin After 12 weeks
Measured: 12 weeks
Change from baseline in Cystatin-C After 12 weeks
Measured: 12 weeks
TSQM-9 scores
Treatment Satisfaction Questionnaire for Medication-9 scores, higher scores mean a better outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653779
- Sponsor's protocol ID
- DA1229_01_DM_IV
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases
- ClinicalTrials.gov ID
- NCT04653779
- Acronym / sponsor ID
- DA1229_01_DM_IV
- Conditions
- Diabetes Mellitus, Type 2, Renal Disease, Diabetes Mellitus, Metabolic Disease, Endocrine System Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 4 Dec 2020 (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.
Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Evogliptin 5mg/Metformin 1000mgPatients receive Evogliptin 5mg/Metformin 1000mg once a day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥60 years
- Subjects with type 2 diabetes mellitus
- Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
- Subjects with HbA1c≤7.5% at screening
- Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
Key exclusion criteria (3 listed)
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- ESRD or Patients who have kidney dialysis
- Subjects with ALT and AST 3 times or higher than upper normal range
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 |
|---|---|---|
| Evogliptin 5mg/Metformin 1000mgAlso: SUGAMET®XR tablet 5/1000mgSize reduction of a tablet formulation | Drug | Group A |
Primary outcome
The preference regarding convenience of medication
Time frame: 12 weeks
Looking back on the experience of participating in the study, which would you prefer, any of the existing DPP-4 inhibitor/metformin 1000mg sustained-release combination drug or the SugarMet® sustained-release tablet 5/1000mg?
9 secondary outcomes
Change from baseline in HbA1c (%) After 12 weeks
Time frame: 12 weeks
Change from baseline in HbA1C response rate(%) After 12 weeks
Time frame: 12 weeks
Change from baseline in Glycated albumin After 12 weeks
Time frame: 12 weeks
Change from baseline in e-GFR After 12 weeks
Time frame: 12 weeks
Change from baseline in UACR After 12 weeks
Time frame: 12 weeks
Change from baseline in HbA1c (%) After 12 weeks NAG
Time frame: 12 weeks
Change from baseline in Nephrin After 12 weeks
Time frame: 12 weeks
Change from baseline in Cystatin-C After 12 weeks
Time frame: 12 weeks
TSQM-9 scores
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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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.
2 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 Evogliptin 5mg/Metformin 1000mg in people with Diabetes Mellitus, Type 2 and Renal Disease, run by Dong-A ST Co., Ltd. at 2 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 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung (82-2-920-8369, jhsung@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The preference regarding convenience of medication (time frame: 12 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 11 Dec 2020.