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

NCT ID: NCT06613750

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-07-01

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.

Conditions

Type 2 Diabetes Mellitus; Glucotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitagliptin and Gliclazide Group

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.

Group Type: EXPERIMENTAL

Sitagliptin and Gliclazide

Intervention Type: DRUG

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

Metformin Group

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Zhibin Xu

OTHER

Sponsor Role: lead

Responsible Party

Zhibin Xu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFKY20240301

Identifier Type: -

Identifier Source: org_study_id