Type 2 DiabetesPhase 3TERA 305NCT05504226
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
A Phase 3 study testing Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet in people with Type 2 Diabetes, run by Handok Inc. at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2022to 18 Jun 2024
- 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 II diabetes mellitus aged 19 years or older
- Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
Who cannot join
- Subjects with type 1 diabetes mellitus or secondary diabetes
- Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
- Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
- Body mass index greater than 40 kg/m2 at the screening visit
- Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin
- Conditions
- Type 2 Diabetes
- Being tested
- Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet, Teneligliptin Placebo Oral Tablet
- 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.
Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral TabletDrug
To be orally administered once daily for 52 weeks.
Teneligliptin Placebo Oral TabletDrug
To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.
| Study group | Role | What they receive |
|---|---|---|
| Teneligliptin 20 mg | Experimental | Not described Receives: Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet |
| Teneligliptin placebo | Placebo comparator | Not described Receives: Drug: Teneligliptin Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline HbA1c at week 24
Measured: Baseline (week 0) and week 24
Secondary outcomes (3)
Changes from baseline FPG at week 24
Measured: Baseline (week 0) and week 24
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
Measured: Baseline (week 0) and week 24
Changes from baseline in BMI at week 24
Measured: Baseline (week 0) and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start12 Oct 2022
- Primary completion30 Nov 2023
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 214 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
- NCT05504226
- Sponsor's protocol ID
- HD-MP-305
- Acronym
- TERA 305
- Status last verified
- Jan 2025
- First submitted
- 11 Aug 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moon JS, Han KA, Kim DL, Kim SY, Kim SK, Ku BJ, Lee WJ, Oh TK, Seo JA, Chang SA, Lee MK, Ahn KJ, Kim CS, Kim TN, Cha BS. A 52-Week Efficacy and Safety Study of Teneligliptin, as an Add-On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial (TERA305 Study). Diabetes Obes Metab. 2026 Oct 5. doi: 10.1111/dom.71315. Online ahead of print.
PubMed 42832816
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg
- ClinicalTrials.gov ID
- NCT05504226
- Acronym / sponsor ID
- TERA 305 / HD-MP-305
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 17 Aug 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 objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin
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 |
|---|---|---|
| Teneligliptin 20 mg | Experimental | Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet |
| Teneligliptin placebo | Placebo comparator | Drug: Teneligliptin Placebo Oral Tablet |
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 II diabetes mellitus aged 19 years or older
- Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
Key exclusion criteria (5 listed)
- Subjects with type 1 diabetes mellitus or secondary diabetes
- Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
- Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
- Body mass index greater than 40 kg/m2 at the screening visit
- Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
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 |
|---|---|---|
| Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral TabletTo be orally administered once daily for 52 weeks. | Drug | Teneligliptin 20 mg |
| Teneligliptin Placebo Oral TabletTo be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24. | Drug | Teneligliptin placebo |
Primary outcome
Changes from baseline HbA1c at week 24
Time frame: Baseline (week 0) and week 24
3 secondary outcomes
Changes from baseline FPG at week 24
Time frame: Baseline (week 0) and week 24
Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24
Time frame: Baseline (week 0) and week 24
Changes from baseline in BMI at week 24
Time frame: Baseline (week 0) and week 24
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 27 Jan 2025.
- Derived from this study: PubMed 42832816Moon JS, Han KA, Kim DL, Kim SY, Kim SK, Ku BJ, Lee WJ, Oh TK, Seo JA, Chang SA, Lee MK, Ahn KJ, Kim CS, Kim TN, Cha BS. A 52-Week Efficacy and Safety Study of Teneligliptin, as an Add-On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial (TERA305 Study). Diabetes Obes Metab. 2026 Oct 5. doi: 10.1111/dom.71315. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet in people with Type 2 Diabetes, 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 3 inclusion and 5 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 27 Jan 2025. 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?
Changes from baseline HbA1c at week 24 (time frame: Baseline (week 0) and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05504226, which also lists 1 linked publication.
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 27 Jan 2025.