Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

Phase 4

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Drug: Linagliptin; Drug: Teneligliptin

• Registration Number: NCT03011177
• Lead Sponsor: Handok Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linagliptin	Linagliptin	linagliptin 5mg qd
teneligliptin	Teneligliptin	teneligliptin 20mg qd

Primary Outcome Measures

Name	Time	Method
HbA1c	12week

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of