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NCT Number: NCT03793023

Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is aged ≥19 years
  • The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
  • Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior to baseline visit (if patient who has been treated with DPP4 inhibitor and any other antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at least 12 weeks prior to baseline.)
  • Patient with HbA1c≥7.0% at baseline visit
  • Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
  • Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study

Exclusion criteria

  • Patient with hypersensitivity to the Teneligliptin
  • Patient who treat the Teneligliptin prior to baseline visit
  • A pregnant or lactating female patient

Treatment and study plan

Teneligliptin 20mg

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: at 12 weeks after switching to Teneligliptin

    To assess change from baseline in glycated hemoglobin (HbA1c)

Secondary outcomes

  1. Change in HbA1c

    Time frame: at 24, 52 weeks after switching to Teneligliptin

    To assess change from baseline in HbA1c

  2. Change in FBG

    Time frame: at 12, 24, 52 weeks after switching to Teneligliptin

    To assess change from baseline in fasting blood glucose (FBG)

  3. Change in body weight, BMI

    Time frame: at 12, 24, 52 weeks after switching to Teneligliptin

    To assess change from baseline in body weight and body mass index (BMI)

  4. Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)

    Time frame: at 12, 24, 52 weeks after switching to Teneligliptin

    To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride)

  5. The percentage of patients with HbA1c <7.0% and <6.5%

    Time frame: at Weeks 12, 24, and 52 of teneligliptin treatment

    To assess the percentage of patients with HbA1c <7.0% and <6.5%

  6. The percentage of patients with a decrease from baseline in HbA1c

    Time frame: at Weeks 12, 24, and 52 of teneligliptin treatment

    To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%

  7. Safety Outcome

    Time frame: at Weeks 12, 24, and 52 of teneligliptin treatment

    To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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