| Trial ID: | L5095 |
| Source ID: | NCT02924064
|
| Associated Drug: |
Teneligliptin 20mg
|
| Title: |
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02924064/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Teneligliptin 20mg|DRUG: Placebo|DRUG: Metformin ≥ 1000 mg
|
| Outcome Measures: |
Primary: The Changes in HbA1c at Week 24, The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS., at Day 1(baseline) and Week 24 | Secondary: The Changes in Fasting Plasma Glucose (FPG) at Week 24, The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS., at Day 1(baseline) and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Mitsubishi Tanabe Pharma Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
247
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: |Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-09
|
| Completion Date: |
|
| Results First Posted: |
2022-01-28
|
| Last Update Posted: |
2022-03-09
|
| Locations: |
Investigational center, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02924064
|
