| Trial ID: | L3067 |
| Source ID: | NCT04446026
|
| Associated Drug: |
Teneligliptin
|
| Title: |
A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: teneligliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Hb1Ac, Difference between baseline and HbA1c at 12 weeks after treatment with test drug, 12 weeks | Secondary: HbA1c, Difference between baseline and HbA1c at 24 weeks after treatment with test drug, 24 weeks|Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c), Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug, 12 weeks|Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c), Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug, 24 weeks|Fasting glucose, Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug, 12 weeks|Fasting glucose, Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Yonsei University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-07-08
|
| Completion Date: |
2021-05-17
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-09
|
| Locations: |
Yonsei Severance Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT04446026
|
