Sitagliptin for the Treatment of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495881
• Other study ID #: 2020-DM-Sitagliptin
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2023
• Source: Beijing Chao Yang Hospital
• Contact: Jia Liu, MD
• Phone: 010-85231710
• Email: liujia0116[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin 100mg
Sitagliptin 100mg Qd

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change	Changes in HbA1c from baseline at 1 month and 3 months during follow-up	Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Secondary	fasting blood glucose change	Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up	Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
Secondary	HOMA-IR change	Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up	Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
Secondary	Glycated Albumin(GSA)change	Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up	Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up