Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
Phase 3
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT05504226
- Lead Sponsor
- Handok Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teneligliptin 20 mg Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet - Teneligliptin placebo Teneligliptin Placebo Oral Tablet -
- Primary Outcome Measures
Name Time Method Changes from baseline HbA1c at week 24 Baseline (week 0) and week 24
- Secondary Outcome Measures
Name Time Method Changes from baseline FPG at week 24 Baseline (week 0) and week 24 Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24 Baseline (week 0) and week 24 Changes from baseline in BMI at week 24 Baseline (week 0) and week 24
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of