Sitagliptin for the Treatment of Type 2 Diabetes

NCT04495881 | Unknown Phase 4

• 1 other identifier: 2020-DM-Sitagliptin
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• fasting blood glucose change

  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

• Glycated Albumin（GSA）change

  Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up

Study Arms (1)

sitagliptin

EXPERIMENTAL

sitagliptin 100mg

Drug: Sitagliptin 100mg

Interventions

Sitagliptin 100mg DRUG

Sitagliptin 100mg Qd

sitagliptin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (2)

• Wang Q, An Y, Zhang L, Zhang Y, Wang G, Liu J. Regulation of Adropin by Sitagliptin monotherapy in participants with newly diagnosed type 2 Diabetes. BMC Endocr Disord. 2022 Dec 7;22(1):306. doi: 10.1186/s12902-022-01233-x.

  PMID: 36476135 DERIVED

• 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.

  PMID: 33625721 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

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

Study Officials

• Guang Wang, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Liu, MD

CONTACT

010-85231710; liujia0116@126.com

Yan Duan, MD

CONTACT

010-85231711

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Department of Endocrinology

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

CN (1)