Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
Study NCT ID:
NCT06613750
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
Sponsor:
Zhibin Xu
Organization:
Study Overview
Official Title:
Comparative Efficacy and Safety of Sitagliptin Plus Gliclazide SR Versus Metformin in Treatment-Naïve Type 2 Diabetes Patients: A Randomized Non-Inferiority Study
Status:
COMPLETED
Status Verified Date:
2024-09
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:
SG Metformin
Brief Summary:
This study compares the efficacy and safety of sitagliptin phosphate combined with gliclazide sustained-release tablets versus metformin in treatment-naïve patients with type 2 diabetes mellitus (T2DM) and glucotoxicity. The trial assesses glycemic control, patient compliance, and adverse events over a 12-week period using a randomized controlled design to determine the non-inferiority of the combined treatment.
Detailed Description:
In this single-center, prospective, randomized controlled non-inferiority study, treatment-naïve patients with T2DM and glucotoxicity were enrolled to evaluate the comparative efficacy and safety of two therapeutic regimens. The study investigates the combination of sitagliptin phosphate with gliclazide sustained-release tablets against metformin alone. Participants were randomized and monitored for 12 weeks, with primary outcomes focusing on fasting plasma glucose (FPG) levels, body weight changes, and hypoglycemic events. The study also explores the impact of treatment on β-cell function and insulin sensitivity, utilizing pharmacogenomic analysis to evaluate genetic factors influencing treatment response.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: