T2DMPhase 3NCT01990469
Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin
A Phase 3 study testing Gemigliptin in people with T2DM, run by LG Life Sciences.
Trial summary
After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- T2DM
- What is being tested?
- Gemigliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with Type 2 Diabetes Mellitus
- Adults aged ≥ 19 years old
- Patients with HbA1c 7%~11% at Visit 1
Who cannot join
None listed.
About this study
After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.
Read the detailed description
Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.
- Conditions
- T2DM
- Being tested
- Gemigliptin, Gemigliptin placebo
- Keywords
- Type 2 Diabetes Mellitus
- 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.
GemigliptinDrug
Also called Zemiglo
DPP-4 inhibitor
Gemigliptin placeboDrug
Placebo of Gemigliptin
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin | Experimental | Gemigliptin 50mg qd Receives: Drug: Gemigliptin |
| Placebo | Placebo comparator | Gemigliptin placebo Receives: Drug: Gemigliptin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbAlc from baseline at Week 24
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 posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990469
- Sponsor's protocol ID
- LG-DPCL010
- Status last verified
- Apr 2016
- First submitted
- 15 Nov 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin
- ClinicalTrials.gov ID
- NCT01990469
- Acronym / sponsor ID
- LG-DPCL010
- Conditions
- T2DM
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.
Detailed description
Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin | Experimental | Drug: GemigliptinGemigliptin 50mg qd |
| Placebo | Placebo comparator | Drug: Gemigliptin placeboGemigliptin placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Type 2 Diabetes Mellitus
- Adults aged ≥ 19 years old
- Patients with HbA1c 7%~11% at Visit 1
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GemigliptinAlso: ZemigloDPP-4 inhibitor | Drug | Gemigliptin |
| Gemigliptin placeboPlacebo of Gemigliptin | Drug | Placebo |
Primary outcome
Change of HbAlc from baseline at Week 24
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemigliptin in people with T2DM, run by LG Life Sciences.
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 3 inclusion and 0 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HbAlc from baseline at Week 24 (time frame: 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 19 Apr 2016.