Type2 Diabetes MellitusPhase 4TELIUSNCT03011177
Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients
A Phase 4 study testing Teneligliptin and Linagliptin in people with Type2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Teneligliptin and Linagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Sep 2018
- Phase
- Phase 4
- 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 who are 19 years or older on screening
- Patients with type 2 diabetes mellitus
- Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
- Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.
Read the detailed description
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Teneligliptin, Linagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeneligliptinDrug
teneligliptin 20mg qd
LinagliptinDrug
linagliptin 5mg qd
| Study group | Role | What they receive |
|---|---|---|
| teneligliptin | Experimental | teneligliptin 20mg qd Receives: Drug: Teneligliptin |
| linagliptin | Active comparator | linagliptin 5mg qd Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011177
- Sponsor's protocol ID
- MP_C402
- Acronym
- TELIUS
- Status last verified
- Feb 2019
- First submitted
- 3 Jan 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT03011177
- Acronym / sponsor ID
- TELIUS / MP_C402
- Conditions
- Type2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 5 Jan 2017 (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.
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.
Detailed description
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| teneligliptin | Experimental | Drug: Teneligliptinteneligliptin 20mg qd |
| linagliptin | Active comparator | Drug: Linagliptinlinagliptin 5mg qd |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are 19 years or older on screening
- Patients with type 2 diabetes mellitus
- Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit
- Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening
Key exclusion criteria (1 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 |
|---|---|---|
| Teneligliptinteneligliptin 20mg qd | Drug | teneligliptin |
| Linagliptinlinagliptin 5mg qd | Drug | linagliptin |
Primary outcome
HbA1c
Time frame: 12week
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 22 Feb 2019.
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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?
A Phase 4 study testing Teneligliptin and Linagliptin in people with Type2 Diabetes Mellitus, run by Handok Inc. 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: finished, as of the sponsor's last update on 22 Feb 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 12week). 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 22 Feb 2019.