Clinical trial NCT03793023: Observational Study to Evaluate the Efficacy and Safety of Teneligliptin
Official title: Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-04
Enrollment: 2983
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 DM patients

Brief summary: This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control


Eligibility criteria: Inclusion Criteria:

1. The subject is aged ≥19 years
2. The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
3. Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior to baseline visit (if patient who has been treated with DPP4 inhibitor and any other antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at least 12 weeks prior to baseline.)
4. Patient with HbA1c≥7.0% at baseline visit
5. Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
6. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study

Exclusion Criteria:

1. Patient with hypersensitivity to the Teneligliptin
2. Patient who treat the Teneligliptin prior to baseline visit
3. A pregnant or lactating female patient

Primary outcomes:
measure: Change in HbA1c
timeFrame: at 12 weeks after switching to Teneligliptin
Secondary outcomes:
measure: Change in HbA1c
timeFrame: at 24, 52 weeks after switching to Teneligliptin
measure: Change in FBG
timeFrame: at 12, 24, 52 weeks after switching to Teneligliptin
measure: Change in body weight, BMI
timeFrame: at 12, 24, 52 weeks after switching to Teneligliptin
measure: Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)
timeFrame: at 12, 24, 52 weeks after switching to Teneligliptin
measure: The percentage of patients with HbA1c <7.0% and <6.5%
timeFrame: at Weeks 12, 24, and 52 of teneligliptin treatment
measure: The percentage of patients with a decrease from baseline in HbA1c
timeFrame: at Weeks 12, 24, and 52 of teneligliptin treatment
measure: Safety Outcome
timeFrame: at Weeks 12, 24, and 52 of teneligliptin treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi
Study officials:
affiliation: Ajou University School of Medicine
name: Kwan Woo Lee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Kim YS, Lee CB, Choi MG, Chang HJ, Kim SK, Yu JM, Kim TH, Lee JH, Ahn KJ, Kim K, Lee KW. Efficacy and Safety of Switching to Teneligliptin in Patients with Type 2 Diabetes Inadequately Controlled with Dipeptidyl Peptidase-4 Inhibitors: A 12-Week Interim Report. Diabetes Ther. 2019 Aug;10(4):1271-1282. doi: 10.1007/s13300-019-0628-0. Epub 2019 May 11.