Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
NCT ID: NCT05504226
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2022-10-12
2024-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Teneligliptin 20 mg
Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
To be orally administered once daily for 52 weeks.
Teneligliptin placebo
Teneligliptin Placebo Oral Tablet
To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.
Interventions
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Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
To be orally administered once daily for 52 weeks.
Teneligliptin Placebo Oral Tablet
To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.
Eligibility Criteria
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Inclusion Criteria
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Handok Inc.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HD-MP-305
Identifier Type: -
Identifier Source: org_study_id
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