Type 2 Diabetes MellitusNCT05281029
Observational Study Gemigliptin in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus, run by LG Chem at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2021to 31 Oct 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Primary care clinic, secondary and tertiary hospital
Who may be able to join
- Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form
Who cannot join
- Patients with previous exposure to gemigliptin and current participation in clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
Severance Hospital
About this study
Official title: A Multicenter, Single-arm, Prospective Observational Study to Evaluate the Safety and Effectiveness of Gemigliptin (as Monotherapy or as Single Pill Combinations) in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of HbA1c at 24 weeks
Measured: Baseline, 24 weeks
Secondary outcomes (2)
Change from Baseline of HbA1c at 12 weeks
Measured: Baseline, 12 weeks
The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start24 Jun 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281029
- Sponsor's protocol ID
- LG-DPOS002
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Prospective Observational Study to Evaluate the Safety and Effectiveness of Gemigliptin (as Monotherapy or as Single Pill Combinations) in Patients Aged ≥ 65 Years With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05281029
- Acronym / sponsor ID
- LG-DPOS002
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 15 Mar 2022 (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.
The aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in Korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Primary care clinic, secondary and tertiary hospital
Key inclusion criteria (1 listed)
- Patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form
Key exclusion criteria (1 listed)
- Patients with previous exposure to gemigliptin and current participation in clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline of HbA1c at 24 weeks
Time frame: Baseline, 24 weeks
2 secondary outcomes
Change from Baseline of HbA1c at 12 weeks
Time frame: Baseline, 12 weeks
The rate of subjects who reached the target value of less than 7% (reasonable HbA1c goal) of HbA1c.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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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.
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 LG Chem 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 1 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 16 Mar 2022. 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 Study Lead (+82-2-3777-1114, jihyun.heo@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of HbA1c at 24 weeks (time frame: Baseline, 24 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 16 Mar 2022.