Tenelia Elderly CGMS Study(TEDDY)

NCT ID: NCT03508323

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2019-12-12

Brief Summary

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

Detailed Description

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

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Teneligliptin

Group Type EXPERIMENTAL

Teneligliptin

Intervention Type DRUG

20mg/qd

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1T/qd

Interventions

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Teneligliptin

20mg/qd

Intervention Type DRUG

Placebo

1T/qd

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Handok Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JH Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Bae JC, Kwak SH, Kim HJ, Kim SY, Hwang YC, Suh S, Hyun BJ, Cha JE, Won JC, Kim JH. Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study). Diabetes Metab J. 2022 Jan;46(1):81-92. doi: 10.4093/dmj.2021.0016. Epub 2021 Jun 16.

Reference Type DERIVED
PMID: 34130378 (View on PubMed)

Other Identifiers

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MP_C403

Identifier Type: -

Identifier Source: org_study_id

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