A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen

NCT04446026 | Completed Phase 4

• 1 other identifier: 4-2020-0488
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses (metformin \>= 1000mg/d, Glimepiride \>=4 mg/day, Gliclazide \>= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA) will be included. Using randomization, patients would take either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients who achieved a glycemic goal (HbA1c \<=7%) at 12th and 24th weeks will be evaluated.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hb1Ac

  Difference between baseline and HbA1c at 12 weeks after treatment with test drug

  12 weeks

Secondary Outcomes (5)

• HbA1c

  24 weeks

• Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)

  12 weeks

• Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)

  24 weeks

• Fasting glucose

  12 weeks

• Fasting glucose

  24 weeks

Study Arms (2)

teneligliptin

EXPERIMENTAL

Drug: teneligliptin

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

teneligliptin DRUG

teneligliptin 20mg PO qd for 24weeks

teneligliptin

Placebo DRUG

teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks

placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years and less than 81 years
• Patients with type 2 diabetes prescribed with triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses (metformin \>= 1000mg/d, Glimepiride \>=4 mg/day, Gliclazide \>= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA)
• Uncontrolled hyperglycemia with 7.1% ≤ HbA1c ≤ 9% at randomization period
• Recommended to use insulin by physicians
• Patients able to understand study protocol and cooperative
• Voluntary consent to participation of study after understanding study protocol

You may not qualify if:

• Type 1 diabetes, gestational diabetes, other than type 2 diabetes
• Insulin treatment more than 1 week (not necessarily continuous use) prior to screening visit within 1 year
• Hypersensitivity to TENELIA tablet including main and other component
• Use of DPP4 inhibitor more than 1 week prior to screening visit within 3 months or discontinuation of DPP4 inhibitor due to severe side effects regardless of treatment period
• History of acute or chronic metabolic acidosis and ketosis including diabetic ketoacidosis with/without comma prior to screening visit within 12 weeks
• Genetic trait of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption
• Difficulty in oral ingestion of drug owing to anatomical abnormalities in head and neck area, or owing to abnormalities in central nervous system
• Steroid use including per oral and non-oral more than 14 consecutive days prior to screening visit within 8 weeks (inhaled steroid use is permitted)
• Histories of any malignancy prior to screening visit within 5 years
• History of congestive heart failure (\>= 10) NYHA class III)
• Uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attack, cerebrovascular disease prior to screening visit within 24 weeks
• Initiation of statin to treat dyslipidemia prior to screening visit within 4 weeks or anticipated increasing dose of statin during study period
• Renal failure, chronic kidney disease stage \<=3 (estimated glomerular filtration rate \<30 mL/min/1.73 m2, calculated using EKD-EPI) or patients with dialysis
• Abnormalities in liver function test: AST, ALT, or ALP \>= 2.5 fold of ULN or patients with liver cirrhosis (Child-Pugh class B or C)
• Infection of HIV, HBV, or HCV and patients subjected to anti-viral therapy within 1 year

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 8, 2020
• Primary Completion: December 7, 2020
• Study Completion: May 17, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)