Clinical trial NCT06613750: Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
Official title: Comparative Efficacy and Safety of Sitagliptin Plus Gliclazide SR Versus Metformin in Treatment-Naïve Type 2 Diabetes Patients: A Randomized Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Glucotoxicity
Keywords: Sitagliptin
Gliclazide
Metformin
Randomized Controlled Trial
Non-Inferiority Study
Glycemic Control
β-Cell Function
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
First posted: 2024-09-26
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) Levels from Baseline to 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) and Body Mass Index (BMI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: