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NCT05504226 | RECRUITING | Type 2 Diabetes

Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
Sponsor:

Handok Inc.

Brief Summary:

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

Condition or disease

Type 2 Diabetes

Intervention/treatment

Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet

Teneligliptin Placebo Oral Tablet

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 208 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg
Actual Study Start Date : 2022-10
Estimated Primary Completion Date : 2024-11
Estimated Study Completion Date : 2025-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin

Location Details

NCT05504226

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,