Tenelia Elderly CGMS Study(TEDDY)

• Sponsor: Handok Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03508323
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.3
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Teneligliptin; Drug: Placebo	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 3, 2018
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Dec 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teneligliptin	Drug: Teneligliptin; 20mg/qd
Placebo Comparator: Placebo	Drug: Placebo; 1T/qd

Outcome Measures

Primary Outcome Measures

1. HbA1c [after 12wks on baseline]

   Change of HbA1c

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Handok Inc.

Investigators

• Principal Investigator: JH Kim, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT03508323
• Other Study ID Numbers: MP_C403
• First Posted: Apr 25, 2018
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 30, 2022