ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03793023
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.

Brief Summary:
This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Teneligliptin 20mg

Study Type : Observational
Estimated Enrollment : 4875 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: at 12 weeks after switching to Teneligliptin ]
    To assess change from baseline in glycated hemoglobin (HbA1c)


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: at 24, 52 weeks after switching to Teneligliptin ]
    To assess change from baseline in HbA1c

  2. Change in FBG [ Time Frame: at 12, 24, 52 weeks after switching to Teneligliptin ]
    To assess change from baseline in fasting blood glucose (FBG)

  3. Change in body weight, BMI [ Time Frame: at 12, 24, 52 weeks after switching to Teneligliptin ]
    To assess change from baseline in body weight and body mass index (BMI)

  4. Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol) [ Time Frame: at 12, 24, 52 weeks after switching to Teneligliptin ]
    To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride)

  5. The percentage of patients with HbA1c <7.0% and <6.5% [ Time Frame: at Weeks 12, 24, and 52 of teneligliptin treatment ]
    To assess the percentage of patients with HbA1c <7.0% and <6.5%

  6. The percentage of patients with a decrease from baseline in HbA1c [ Time Frame: at Weeks 12, 24, and 52 of teneligliptin treatment ]
    To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%

  7. Safety Outcome [ Time Frame: at Weeks 12, 24, and 52 of teneligliptin treatment ]
    To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Type 2 DM patients
Criteria

Inclusion Criteria:

  1. The subject is aged ≥19 years
  2. The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
  3. Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior to baseline visit (if patient who has been treated with DPP4 inhibitor and any other antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at least 12 weeks prior to baseline.)
  4. Patient with HbA1c≥7.0% at baseline visit
  5. Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
  6. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study

Exclusion Criteria:

  1. Patient with hypersensitivity to the Teneligliptin
  2. Patient who treat the Teneligliptin prior to baseline visit
  3. A pregnant or lactating female patient

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): NCT03793023


Contacts
Contact: Yeokyung Kim, CRM +82-2-527-5332 YeoKyeong.Kim@handok.com
Contact: Yesung Jang, CRA +82-2-527-5383 yesung.Jang@handok.com

Locations
Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Gyeonggi, Korea, Republic of
Contact: Kwan Woo Lee, M.D, Ph.D         
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Kwan Woo Lee, MD, Ph.D Ajou University School of Medicine

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03793023     History of Changes
Other Study ID Numbers: HD_TEN_OS2015
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases