Glucotoxicity, Type 2 Diabetes Mellitus
Conditions
Keywords
Sitagliptin, Gliclazide, Metformin, Randomized Controlled Trial, Non-Inferiority Study, Glycemic Control, β-Cell Function
Brief 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.
Interventions
DRUGSitagliptin 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
DRUGMetformin
Participants in this arm will receive metformin 500 mg to 2000 mg per day, divided into two doses, for 12 weeks
Sponsors
Nanfang Hospital, Southern Medical University
Zhibin Xu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a parallel-group, randomized, controlled, non-inferiority study comparing the efficacy and safety of Sitagliptin Phosphate combined with Gliclazide sustained-release tablets versus Metformin in treatment-naïve patients with Type 2 Diabetes Mellitus and glucotoxicity. Participants will be randomly assigned to one of two treatment arms and followed for 12 months to evaluate glycemic control and safety outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) Levels from Baseline to 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) and Body Mass Index (BMI) | 12 weeks | 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. |
Countries
China
Outcome results
None listed