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NCT03508323 Clinical Trial

Tenelia Elderly CGMS Study(TEDDY)

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03508323
Other study ID # MP_C403
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 3, 2018
Est. completion date December 12, 2019

Study information
Verified date June 2022
Source Handok Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date December 12, 2019
Est. primary completion date December 12, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Teneligliptin
20mg/qd
• Placebo
1T/qd

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Handok Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Change of HbA1c after 12wks on baseline
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