Type 2 Diabetes MellitusSSUGNCT04267601
Korean Observational Study to Evaluate the Efficacy and Safety of Anagliptin Switching From Other DPP4is in type2 DM
An observational study of Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Anagliptin
- How many people
- 2,448 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2017to 30 Sep 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 diabetic patients with other DPP4is as mono or combination therapy with insufficient glucose control
Who may be able to join
- 19 years of age at the time of consenting
- Understands and is willing to sign an informed consent form (ICF)
- HbA1c≥7.0%
- within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks
Who cannot join
- Prior exposure to Anagliptin
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Bucheon ST. Mary's hopsital
Bucheon-si, 14647
About this study
Official title: A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control
This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.
Read the detailed description
Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.
Primary endpoint
- HbA1c change after 24 weeks treatment
Secondary endpoint
- Average rate of change in HbA1c after baseline
- Ratio of subjects with HbA1c<7% after 24 weeks
- Ratio of subjects with HbA1c<6.5% after 24 weeks
- Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease
Safety endpoint : Adverse Event
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Anagliptin
- 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.
AnagliptinDrug
Anagliptin treatment for 24weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1C
Measured: after 24weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start6 Jul 2017
- Primary completion30 Mar 2021
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267601
- Sponsor's protocol ID
- JWP-GDL-402
- Acronym
- SSUG
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Single Group, Open-label, Multicenter Observational Study to Evaluate the Efficacy and Safety of Anagliptin in Type 2 Diabetic Patients With Other DPP4is as Mono or Combination Therapy With Insufficient Glucose Control
- ClinicalTrials.gov ID
- NCT04267601
- Acronym / sponsor ID
- SSUG / JWP-GDL-402
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,448 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 13 Feb 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.
This study was designed as a non-interventional, single-group, open-label, multicenter observational study for patients with type 2 diabetes in the real world clinical setting.
Detailed description
Subjects will visit the site on the 12th week (Visit 2) and 24th week (Visit 3) from the registration date (Visit 1) to confirm the efficacy and safety.
Primary endpoint
- HbA1c change after 24 weeks treatment
Secondary endpoint
- Average rate of change in HbA1c after baseline
- Ratio of subjects with HbA1c<7% after 24 weeks
- Ratio of subjects with HbA1c<6.5% after 24 weeks
- Subgroup analysis by gender, age, BMI, medical history, renal function, liver function, conventional DPP4 inhibitors therapy, concomitant Oral Antidiabetic Drug, duration of disease
Safety endpoint : Adverse Event
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients with other DPP4is as mono or combination therapy with insufficient glucose control
Key inclusion criteria (4 listed)
- 19 years of age at the time of consenting
- Understands and is willing to sign an informed consent form (ICF)
- HbA1c≥7.0%
- within 7days before registration, continuing other DPP4is alone or combined therapy for than 8 weeks
Key exclusion criteria (1 listed)
- Prior exposure to Anagliptin
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 |
|---|---|---|
| AnagliptinAnagliptin treatment for 24weeks | Drug | – |
Primary outcome
Change of HbA1C
Time frame: after 24weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Type 2 Diabetes Mellitus, run by JW Pharmaceutical 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 4 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 29 Apr 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?
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?
Change of HbA1C (time frame: after 24weeks treatment). 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 29 Apr 2021.