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

NCT06613750 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

DRUG

Metformin

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Zhibin Xu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-06-30
Completion
2024-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613750 on ClinicalTrials.gov