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Sitagliptin for the Treatment of Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sitagliptin 100mg
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sitagliptin

Arm Description

sitagliptin 100mg

Outcomes

Primary Outcome Measures

HbA1c change
Changes in HbA1c from baseline at 1 month and 3 months during follow-up

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2020
Last Updated
July 27, 2023
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04495881
Brief Title
Sitagliptin for the Treatment of Type 2 Diabetes
Official Title
Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sitagliptin
Arm Type
Experimental
Arm Description
sitagliptin 100mg
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Intervention Description
Sitagliptin 100mg Qd
Primary Outcome Measure Information:
Title
HbA1c change
Description
Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Time Frame
Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Secondary Outcome Measure Information:
Title
fasting blood glucose change
Description
Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
Time Frame
Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up
Title
HOMA-IR change
Description
Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
Time Frame
Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up
Title
Glycated Albumin（GSA）change
Description
Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up
Time Frame
Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Liu, MD
Phone
010-85231710
Email
liujia0116@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Duan, MD
Phone
010-85231711
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Wang, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia liu, MD
Phone
861085231710
Email
liujia0116@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33625721
Citation
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.
Results Reference
derived

Learn more about this trial

Sitagliptin for the Treatment of Type 2 Diabetes

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