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

Zhibin Xu129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Type 2 Diabetes Mellitus Glucotoxicity

Interventions

Sitagliptin and GliclazideDRUG

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

MetforminDRUG

Participants in this arm will receive metformin 500 mg to 2000 mg per day, divided into two doses, for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) and glucotoxicity. * Body Mass Index (BMI) between 18 and 30 kg/m². * Fasting plasma glucose (FPG) levels ≥ 200 mg/dL and glycated hemoglobin (HbA1c) ≥ 9.0%. * Normal hepatic and renal functions (ALT and AST ≤ 2.5 times the upper limit of normal; serum creatinine within normal limits). * Capable of adhering to the prescribed anti-diabetic regimen and dietary guidelines. Exclusion Criteria: * Diagnosis of Type 1 Diabetes Mellitus. * Hepatic or renal dysfunction (serum creatinine \> 1.2 times the upper limit of normal). * Prior use of hypoglycemic medications before screening. * History of severe ketosis, ketoacidosis, or hyperosmolar hyperglycemic state. * Current treatment with corticosteroids, immunosuppressive agents, or cytotoxic drugs. * Major systemic diseases (e.g., cardiovascular, respiratory, neurological). * Pregnant or breastfeeding women. * Known allergies to sitagliptin or gliclazide. * Poor compliance potential as assessed by the investigator.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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