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Tenelia Elderly CGMS Study(TEDDY)

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03508323
Enrollment
65
Registered
2018-04-25
Start date
2018-04-03
Completion date
2019-12-12
Last updated
2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Detailed description

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

Interventions

20mg/qd

DRUGPlacebo

1T/qd

Sponsors

Handok Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
HbA1cafter 12wks on baselineChange of HbA1c

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026