A Phase 4 interventional study of Sitagliptin and Gliclazide and Metformin in Type 2 Diabetes Mellitus and Glucotoxicity, sponsored by Zhibin Xu. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Zhibin Xu · Phase 4, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 129 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Zhibin Xu is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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: Sitagliptin and Gliclazide
Participants in this arm will receive metformin 500 mg to 2000 mg per day, divided into two doses, for 12 weeks.
Drug: Metformin
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
Participants in this arm will receive metformin 500 mg to 2000 mg per day, divided into two doses, for 12 weeks
Change in Glycated Hemoglobin (HbA1c) Levels from Baseline to 12 Weeks
This outcome measures the change in HbA1c levels in participants over a 12-week period, comparing sitagliptin and gliclazide treatments with metformin for type 2 diabetes mellitus patients with glucotoxicity.
Time frame: 12 weeks
Change in Fasting Plasma Glucose (FPG) and Body Mass Index (BMI)
Secondary outcomes include changes in FPG, BMI, and the proportion of participants achieving FPG levels below 6.1 mmol/L and 7.2 mmol/L after 12 weeks of treatment.
Time frame: 12 weeks
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Zhibin Xu