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

NCT05504226 | Completed Phase 3

• 1 other identifier: HD-MP-305
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes from baseline HbA1c at week 24

  Baseline (week 0) and week 24

Secondary Outcomes (3)

• Changes from baseline FPG at week 24

  Baseline (week 0) and week 24

• Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24

  Baseline (week 0) and week 24

• Changes from baseline in BMI at week 24

  Baseline (week 0) and week 24

Study Arms (2)

Teneligliptin 20 mg

EXPERIMENTAL

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

Teneligliptin placebo

PLACEBO COMPARATOR

Drug: Teneligliptin Placebo Oral Tablet

Interventions

Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet DRUG

To be orally administered once daily for 52 weeks.

Teneligliptin 20 mg

Teneligliptin Placebo Oral Tablet DRUG

To be orally administered once daily for 52 weeks. This arm will be switched to teneligliptin from week 24.

Teneligliptin placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 17, 2022
• Study Start: October 12, 2022
• Primary Completion: November 30, 2023
• Study Completion: June 18, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (1)