Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients (TELIUS)

Handok

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes Mellitus

Treatments: Drug: Teneligliptin; Drug: Linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03011177

MP_C402

Details and patient eligibility

About

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

Full description

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

Enrollment: 168 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

teneligliptin

Experimental group

Description:

teneligliptin 20mg qd

Treatment:

Drug: Teneligliptin

linagliptin

Active Comparator group

Description:

linagliptin 5mg qd

Treatment:

Drug: Linagliptin