Diabetes Mellitus, Type 2NCT04326166
Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab.
An observational study of Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Evogliptin and Metformin and Evogliptin
- How many people
- 1,971 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2020to 31 Jul 2021
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 DM patients
Who may be able to join
- The subject is aged ≥19 years
- The subject has type 2 diabetes mellitus
Who cannot join
- 1. The subject has a contraindication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sanggye paik pospital
Seoul, Nowon-gu, 01757
Jongchul Won, M.D., Ph.D., +82-2-950-8860, drwonjc@gmail.com
About this study
Official title: Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes
Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Evogliptin, Metformin and Evogliptin
- 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.
EvogliptinDrug
Also called Suganon, Sugamet XR
Evogliptin
EvogliptinDrug
Also called Suganon, Sugamet XR
Evogliptin
Metformin and EvogliptinDrug
Also called Suganon, Sugamet XR
Metformin and Evogliptin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who receive Double therapy or Insulin Receives: Drug: Evogliptin | |
| Group B | Patients who receive DPP-4 inhibitor Receives: Drug: Evogliptin | |
| Group C | Drug-naïve patients Receives: Drug: Metformin and Evogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
To assess change from baseline in HbA1c
Measured: at 12 weeks
Secondary outcomes (3)
Change in HbA1c
To assess change from baseline in HbA1c
Measured: at 24 weeks
The percentage of patients with HbA1c <7.0% and <6.5%
To assess the percentage of patients with HbA1c <7.0% and <6.5%
Measured: at 12 and 24 weeks
Change in FPG
To assess change from baseline in fasting plasma glucose (FPG)
Measured: at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start25 Mar 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,971 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
- NCT04326166
- Sponsor's protocol ID
- DA1229_DM_OS
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JE, Hong JH, Yu SH, Baek KH, Yu J, Lee SJ, Kim HW, Park KS, Kim JH, Min K, Lee YH, Kim KS, Song MS, Kim JH, Won JC. Role of Evogliptin for Intra-Class Therapeutic Interchange in Patients With Type 2 Diabetes Mellitus: Subgroup Analysis From A Multi-Center, Prospective, Observational Study (REVISE Study). Endocrinol Diabetes Metab. 2026 Jul;9(4):e70270. doi: 10.1002/edm2.70270.
PubMed 42383539
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04326166
- Acronym / sponsor ID
- DA1229_DM_OS
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,971 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 30 Mar 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, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: EvogliptinPatients who receive Double therapy or Insulin |
| Group B | – | Drug: EvogliptinPatients who receive DPP-4 inhibitor |
| Group C | – | Drug: Metformin and EvogliptinDrug-naïve patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 DM patients
Key inclusion criteria (2 listed)
- The subject is aged ≥19 years
- The subject has type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- 1. The subject has a contraindication
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 |
|---|---|---|
| EvogliptinAlso: Suganon, Sugamet XREvogliptin | Drug | Group A |
| EvogliptinAlso: Suganon, Sugamet XREvogliptin | Drug | Group B |
| Metformin and EvogliptinAlso: Suganon, Sugamet XRMetformin and Evogliptin | Drug | Group C |
Primary outcome
Change in HbA1c
Time frame: at 12 weeks
To assess change from baseline in HbA1c
3 secondary outcomes
Change in HbA1c
Time frame: at 24 weeks
The percentage of patients with HbA1c <7.0% and <6.5%
Time frame: at 12 and 24 weeks
Change in FPG
Time frame: at 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 42383539Lee JE, Hong JH, Yu SH, Baek KH, Yu J, Lee SJ, Kim HW, Park KS, Kim JH, Min K, Lee YH, Kim KS, Song MS, Kim JH, Won JC. Role of Evogliptin for Intra-Class Therapeutic Interchange in Patients With Type 2 Diabetes Mellitus: Subgroup Analysis From A Multi-Center, Prospective, Observational Study (REVISE Study). Endocrinol Diabetes Metab. 2026 Jul;9(4):e70270. doi: 10.1002/edm2.70270.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. 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 2 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 17 Feb 2021. 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.
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 Jongchul Won, M.D., Ph.D. (+82-2-950-8860, dronjc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326166, which also lists 1 linked publication.
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 Feb 2021.