NCT06613750CompletedPhase 4
Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity
Comparative Efficacy and Safety of Sitagliptin Plus Gliclazide SR Versus Metformin in Treatment-Naïve Type 2 Diabetes Patients: A Randomized Non-Inferiority Study
Source: ClinicalTrials.gov · Last updated 26 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 23 Sept 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Zhibin Xu
- Diseases
- Type 2 diabetes
- NCT number
- NCT06613750
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 129
- From 1 Jun 2024 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of hypoglycemic medications before screening.
- Current treatment with corticosteroids, immunosuppressive agents, or cytotoxic drugs.
Other illness
- Diagnosis of Type 1 Diabetes Mellitus.
- History of severe ketosis, ketoacidosis, or hyperosmolar hyperglycemic state.
- Major systemic diseases (e.g., cardiovascular, respiratory, neurological).
- Known allergies to sitagliptin or gliclazide.
Lab values
- Hepatic or renal dysfunction (serum creatinine \> 1.2 times the upper limit of normal).
Other
- Pregnant or breastfeeding women.
- Poor compliance potential as assessed by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.