TELIUS: Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

• Sponsor: Handok Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03011177
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus	Drug: Teneligliptin; Drug: Linagliptin	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: teneligliptin teneligliptin 20mg qd	Drug: Teneligliptin; teneligliptin 20mg qd
Active Comparator: linagliptin linagliptin 5mg qd	Drug: Linagliptin; linagliptin 5mg qd

Outcome Measures

Primary Outcome Measures

1. HbA1c [12week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Handok Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT03011177
• Other Study ID Numbers: MP_C402
• First Posted: Jan 5, 2017
• Last Update Posted: Feb 22, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Linagliptin

Study Results

No Results Posted as of Feb 22, 2019