Type 2 Diabetes Mellitus
Conditions
Brief summary
After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.
Detailed description
Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.
Interventions
DRUGTeneligliptin
Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.
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
1. Patients with Type 2 Diabetes Mellitus 2. Adults aged ≥ 19 years old 3. Patients with HbA1c 7%\ 11% at Screening and Run-in visit
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of HbAlc from baseline at Week 24 | 24 weeks |
Countries
South Korea
Outcome results
None listed