Observational Study to Evaluate the Efficacy and Safety of Teneligliptin

• Sponsor: Handok Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03793023
• Collaborator: (none)
• Enrollment: 4,875
• Location: 1
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 82.6

Study Details

Study Description

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	Phase
Type 2 Diabetes Mellitus	Drug: Teneligliptin 20mg

Study Design

• Study Type: Observational
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [at 12 weeks after switching to Teneligliptin]

   To assess change from baseline in glycated hemoglobin (HbA1c)

Secondary Outcome Measures

1. Change in HbA1c [at 24, 52 weeks after switching to Teneligliptin]

   To assess change from baseline in HbA1c

2. Change in FBG [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 [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) [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% [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 [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 [at Weeks 12, 24, and 52 of teneligliptin treatment]

   To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon	Gyeonggi	Korea, Republic of

Sponsors and Collaborators

• Handok Inc.

Investigators

• Principal Investigator: Kwan Woo Lee, MD, Ph.D, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Handok Inc.
• ClinicalTrials.gov Identifier: NCT03793023
• Other Study ID Numbers: HD_TEN_OS2015
• First Posted: Jan 4, 2019
• Last Update Posted: Jan 7, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Type 2

Study Results

No Results Posted as of Jan 7, 2019