Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793023
• Other study ID #: HD_TEN_OS2015
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: Yeokyung Kim, CRM
• Phone: +82-2-527-5332
• Email: YeoKyeong.Kim[@]handok.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4875
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Teneligliptin 20mg

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Change in FBG	To assess change from baseline in fasting blood glucose (FBG)	at 12, 24, 52 weeks after switching to Teneligliptin
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety Outcome	To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)	at Weeks 12, 24, and 52 of teneligliptin treatment