drugset / Trial / NCT06613750

Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity

NCT06613750

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-06-01
Primary completion
2024-06-30
Completion
2024-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gliclazide Small molecule 30 mg
Subject Gliclazide Small molecule 120 mg
Comparator Metformin Small molecule 500 mg
Comparator Metformin Small molecule 2000 mg
Subject Sitagliptin Small molecule 100 mg