Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin (TERA 305)

Handok

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet; Drug: Teneligliptin Placebo Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504226

HD-MP-305

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin

Enrollment: 208 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type II diabetes mellitus aged 19 years or older
• Subjects with 7.0%≤HbA1c≤10.5% at screening visit
• Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion criteria

• Subjects with type 1 diabetes mellitus or secondary diabetes
• Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
• Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
• Body mass index greater than 40 kg/m2 at the screening visit
• Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 2 patient groups, including a placebo group

Teneligliptin 20 mg

Experimental group

Description:

Once daily for 24 weeks

Treatment:

Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet

Teneligliptin placebo

Placebo Comparator group

Description:

Once daily for 24 weeks

Treatment:

Drug: Teneligliptin Placebo Oral Tablet