NCT06613750

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Zhibin Xu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Glucotoxicity

Interventions

Type	Name	Description
DRUG	Sitagliptin and Gliclazide	Participants in this arm will receive sitagliptin phosphate 100 mg once daily combined with gliclazide sustained-release tablets 30-120 mg once daily for 12 weeks
DRUG	Metformin	Participants in this arm will receive metformin 500 mg to 2000 mg per day, divided into two doses, for 12 weeks

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-06-30
• Completion: 2024-07-01
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: China