Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02285205
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-11-04
Brief Title:
A 24 Week Multicenter Prospective Open-labeled Single-arm Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output In vivo It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone Currently thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease NALFD in type 2 diabetes T2D
The aim of this multicenter prospective open-labeled single-arm exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography fibroscan in T2D with NAFLD
Fifty subjects with T2D and NAFLD will take Lobeglitazone 05mgtablet orally 1 tablet once daily for 24 weeks
Primary endpoint is changes from baseline in controlled attenuation parameters CAP measured by transient elastography fibroscan after treatment with Lobeglitazone
Secondary endpoints are changes from baseline in glycemic profiles HbA1c Glycated albumin Lipid parameters Total Cholesterol Triglycerides HDL-C LDL-C Liver function parameters AST ALT r-GT and adverse events during the trial
The aim of this multicenter prospective open-labeled single-arm exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography fibroscan in T2D with NAFLD
Fifty subjects with T2D and NAFLD will take Lobeglitazone 05mgtablet orally 1 tablet once daily for 24 weeks
Primary endpoint is changes from baseline in controlled attenuation parameters CAP measured by transient elastography fibroscan after treatment with Lobeglitazone
Secondary endpoints are changes from baseline in glycemic profiles HbA1c Glycated albumin Lipid parameters Total Cholesterol Triglycerides HDL-C LDL-C Liver function parameters AST ALT r-GT and adverse events during the trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None