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Trial record 2 of 14 for:    TEDDY

Tenelia Elderly CGMS Study(TEDDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508323
Recruitment Status : Active, not recruiting
First Posted : April 25, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Handok Inc.

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 3, 2018
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Teneligliptin Drug: Teneligliptin
20mg/qd

Placebo Comparator: Placebo Drug: Placebo
1T/qd




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 12wks on baseline ]
    Change of HbA1c



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508323


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Inc.
Investigators
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Principal Investigator: JH Kim Samsung Medical Center

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Responsible Party: Handok Inc.
ClinicalTrials.gov Identifier: NCT03508323    
Other Study ID Numbers: MP_C403
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases