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Sitagliptin for the Treatment of Type 2 Diabetes

Sitagliptin for the Treatment of Type 2 Diabetes

Non Recruiting
18-65 years
All
Phase 4

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Overview

Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.

Description

The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). This clinical trial aims to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the patients will be collected to analyze the gut microbiome. All of the patients will receive the sitagliptin treatment for 3 months. The gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.

Eligibility

Inclusion Criteria:

  • Patients 18-65 years old newly diagnosed with type 2 diabetes
  • HbA1c ≥ 7%

Exclusion Criteria:

  • The positive of diabetes antibodies
  • Anti-diabetic drugs therapy before participation
  • Pancreatitis
  • Coronary artery disease
  • Liver function impairment
  • Renal function impairment
  • History of intestinal surgery
  • Chronic hypoxic diseases (emphysema and cor pulmonale)
  • Infectious disease
  • Hematological disease
  • Systemic inflammatory disease
  • Cancer
  • Pregnant
  • Ingesting agents known to influence glucose or lipid metabolism;
  • Any antibiotics or probiotics in the past three months prior to the study.

Study details
    Type 2 Diabetes

NCT04495881

Beijing Chao Yang Hospital

21 October 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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