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

H

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

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

Trial contacts and locations

1

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Central trial contact

SeJin Kim

Data sourced from clinicaltrials.gov

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