Type 2 Diabetes
Conditions
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
Interventions
To be orally administered once daily for 52 weeks.
To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.
Sponsors
Handok Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline HbA1c at week 24 | Baseline (week 0) and week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed