drugset / Trial / NCT06613750
Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |