Tenelia Elderly CGMS Study(TEDDY)

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

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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

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who are 65 years or older on screening
Patients with type 2 diabetes mellitus
Patients with 7.0% ≤ HbA1c ≤ 9.0% at the screening visit
Patients with FPG < 270mg/dL on screening visit

Exclusion criteria

Treatment and study plan

teneligliptin

Drug

20mg/qd

Placebo

Drug

1T/qd

Primary outcomes

HbA1c

Time frame: after 12wks on baseline

Change of HbA1c

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase IV Study to Evaluate the Efficacy and Safety of Tenelia® in Patients Aged 65 and Older With Inadequately Controlled Type 2 Diabetes

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Apr 25, 2018
Registry last updated: Jun 30, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed