Sitagliptin for the Treatment of Type 2 Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Sitagliptin 100mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jia Liu, MD; Phone Number: 010-85231710; Email: liujia0116@126.com
• Study Contact Backup: Name: Yan Duan, MD; Phone Number: 010-85231711

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Chao-yang Hospital, Capital Medical University
      • Contact: Jia liu, MD; Phone Number: 861085231710; Email: liujia0116@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sitagliptin; sitagliptin 100mg	Drug: Sitagliptin 100mg; Sitagliptin 100mg Qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Guang Wang, MD, Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• Wang Q, Ma L, Zhang Y, Zhang L, An Y, Liu J, Wang G. Effect of Sitagliptin on Serum Irisin Levels in Patients with Newly Diagnosed Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Apr;12(4):1029-1039. doi: 10.1007/s13300-021-01023-z. Epub 2021 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 2020-DM-Sitagliptin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No