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

NCT06613750 | Completed Phase 4

• 1 other identifier: NFKY20240301
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Glucotoxicity

Keywords

Sitagliptin; Gliclazide; Metformin; Randomized Controlled Trial; Non-Inferiority Study; Glycemic Control; β-Cell Function

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Change in Fasting Plasma Glucose (FPG) and Body Mass Index (BMI)

  12 weeks

Study Arms (2)

Sitagliptin and Gliclazide Group

EXPERIMENTAL

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: Sitagliptin and Gliclazide

Metformin Group

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Sitagliptin and Gliclazide 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

Sitagliptin and Gliclazide Group

Metformin DRUG

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

Metformin Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhibin Xu: lead
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Gliclazide; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)