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Clinical Trial Details

Trial ID: L4654
Source ID: NCT03793023
Associated Drug: Teneligliptin 20mg
Title: Observational Study to Evaluate the Efficacy and Safety of Teneligliptin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Teneligliptin 20mg
Outcome Measures: Primary: Change in HbA1c, To assess change from baseline in glycated hemoglobin (HbA1c), at 12 weeks after switching to Teneligliptin | Secondary: Change in HbA1c, To assess change from baseline in HbA1c, at 24, 52 weeks after switching to Teneligliptin|Change in FBG, To assess change from baseline in fasting blood glucose (FBG), at 12, 24, 52 weeks after switching to Teneligliptin|Change in body weight, BMI, To assess change from baseline in body weight and body mass index (BMI), at 12, 24, 52 weeks after switching to Teneligliptin|Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol), To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride), at 12, 24, 52 weeks after switching to Teneligliptin|The percentage of patients with HbA1c <7.0% and <6.5%, To assess the percentage of patients with HbA1c \<7.0% and \<6.5%, at Weeks 12, 24, and 52 of teneligliptin treatment|The percentage of patients with a decrease from baseline in HbA1c, To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%, at Weeks 12, 24, and 52 of teneligliptin treatment|Safety Outcome, To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.), at Weeks 12, 24, and 52 of teneligliptin treatment
Sponsor/Collaborators: Sponsor: Handok Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 2983
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2016-01-05
Completion Date: 2019-09-23
Results First Posted:
Last Update Posted: 2025-01-27
Locations: Ajou University Hospital, Suwon, Gyeonggi, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03793023