Tenelia Elderly CGMS Study(TEDDY)

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Teneligliptin; Drug: Placebo

• Registration Number: NCT03508323
• Lead Sponsor: Handok Inc.

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.

Study Timeline

• Study Start: 2018-04-03
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teneligliptin	Teneligliptin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c	after 12wks on baseline	Change of HbA1c

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of