Type 2 Diabetes MellitusPhase 3NCT02946541
A Clinical Trial to Investigate the Efficacy and Safety of Evogliptin
A Phase 3 study testing evogliptin 5mg in people with Type 2 Diabetes Mellitus, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- evogliptin 5mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with 6.5%≤HbA1c≤10.0% at screening
- Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
- Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
- Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Who cannot join
- Subjects with fasting plasma glucose≥270mg/dL at screening
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
- Subjects with ALT and AST 2.5 times or higher than upper normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.
Read the detailed description
- Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
- Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- evogliptin 5mg, Placebo
- Keywords
- DA-1229, evogliptin, DPP-IV inhibitor, Suganon, DPP-4 inhibitor
- 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.
evogliptin 5mgDrug
Also called DA-1229, Suganon
evogliptin 5mg, QD
PlaceboDrug
Placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| evogliptin 5mg | Experimental | evogliptin 5mg QD Receives: Drug: evogliptin 5mg |
| placebo | Placebo comparator | Placebo QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
unit: %
Measured: Change from baseline at 24 weeks
Secondary outcomes (2)
fasting plasma glucose
unit: mg/dL
Measured: Change from baseline at 24 weeks
HbA1c response rate
unit: %
Measured: Change from baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionApr 2015
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
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doo Man Kim, M.D., Ph.D., Principal investigator, Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946541
- Sponsor's protocol ID
- DA1229_DMM_III
- Status last verified
- Mar 2017
- First submitted
- 23 Feb 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin After Oral Administration in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise
- ClinicalTrials.gov ID
- NCT02946541
- Acronym / sponsor ID
- DA1229_DMM_III
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- DA-1229, evogliptin, DPP-IV inhibitor, Suganon, DPP-4 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Oct 2016 (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.
This is a randomized, double-blind, placebo-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin after oral administration in patients with type 2 diabetes who have inadequate glycemic control on diet and exercise.
Detailed description
- Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-52 weeks.
- Placebo Group: Administration with Placebo for 0-24 weeks, and with Evogliptin 5mg for 24-52 weeks.
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 |
|---|---|---|
| evogliptin 5mg | Experimental | Drug: evogliptin 5mgevogliptin 5mg QD |
| placebo | Placebo comparator | Drug: PlaceboPlacebo QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with 6.5%≤HbA1c≤10.0% at screening
- Subjects untreated with oral hypoglycemic agents within 6 weeks prior to screening
- Subjects with 6.5%≤HbA1c≤10.0% at Visit 2
- Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
Key exclusion criteria (4 listed)
- Subjects with fasting plasma glucose≥270mg/dL at screening
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
- Subjects with ALT and AST 2.5 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 5mgAlso: DA-1229, Suganonevogliptin 5mg, QD | Drug | evogliptin 5mg |
| PlaceboPlacebo, QD | Drug | placebo |
Primary outcome
HbA1c
Time frame: Change from baseline at 24 weeks
unit: %
2 secondary outcomes
fasting plasma glucose
Time frame: Change from baseline at 24 weeks
HbA1c response rate
Time frame: Change from baseline at 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 28 Mar 2017.
- 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.
Doo Man Kim, M.D., Ph.D. principal investigator
Kangdong Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing evogliptin 5mg in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 4 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 28 Mar 2017. 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. 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?
HbA1c (time frame: Change from baseline at 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 28 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.