Sitagliptin for the Treatment of Type 2 Diabetes | NCT04495881

Studies
Sitagliptin for the Treatment of Type 2 Diabetes

NCT04495881

Sponsor

Beijing Chao Yang Hospital

Status

Unknown status

Last Update Posted

Jul 28, 2023Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Sitagliptin 100mg

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Jul 29, 2020

First Submission Date that Met QC Criteria

Jul 29, 2020

First Posted Date

Aug 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2023

Last Update Posted Date

Jul 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guang Wang, Professor and Director, Department of Endocrinology, Beijing Chao Yang HospitalPrincipal Investigator

Lead Sponsor

Beijing Chao Yang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sitagliptin	Experimental	sitagliptin 100mg	Drug: Sitagliptin 100mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitagliptin 100mg	Drug	Sitagliptin 100mg Qd	sitagliptin

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jia Liu, MD	Contact	010-85231710		liujia0116@126.com
Yan Duan, MD	Contact	010-85231711

Overall Officials

Name	Affiliation	Role
Guang Wang, MD	Beijing Chao Yang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Chao-Yang Hospital, Capital Medical University	Recruiting	Beijing	Beijing Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36476135	Derived	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.
33625721	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds