Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

Type2 Diabetes Mellitus Clinical Trial

— TELIUS  

Official title:

A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011177
• Other study ID #: MP_C402
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: Handok Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

Description:

A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who are 19 years or older on screening

• Patients with type 2 diabetes mellitus

• Patients with 7.0% = HbA1c = 11.0% at the screening visit

• Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• Teneligliptin
teneligliptin 20mg qd
• Linagliptin
linagliptin 5mg qd

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

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	HbA1c		12week