Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

NCT05667220 | Unknown Phase 4

• 1 other identifier: 2022-Sitagliptin-Beidougen
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study was an interventional non-randomized controlled study and was divided into a Sitagliptin monotherapy (100 mg Qd) group and a Sitagliptin (100mg Qd)+Beidougen capsule (60mg Tid) combination treatment group for one week.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Fasting blood glucose change

  Fasting blood glucose (FBG) levels (mmol/L) were analyzed by an autoanalyzer (Hitachi 747, Roche Diagnostics, Germany) at the Central Chemistry Laboratory of Beijing Chaoyang Hospital affiliated with Capital Medical University.

  Changes in fasting blood glucose from baseline to 1 week treatment

Secondary Outcomes (2)

• Serum GLP-1 change

  Changes in serum GLP-1 from baseline to 1 week treatment

• Fecal DPP4 activity change

  Changes in fecal DPP4 activity from baseline to 1 week treatment

Study Arms (2)

Sitagliptin monotherapy group (Group A)

ACTIVE COMPARATOR

Drug: Sitagliptin

Sitagliptin combined with Beidougen capsule treatment group (Group B)

EXPERIMENTAL

Drug: Sitagliptin combined with Beidougen capsule

Interventions

Sitagliptin DRUG

Sitagliptin monotherapy group (Group A): 20 eligible patients were planned to be included and given Sitagliptin 100 mg Qd orally; the treatment period was 1 week.

Sitagliptin monotherapy group (Group A)

Sitagliptin combined with Beidougen capsule DRUG

Sitagliptin combined with Beidougen capsule treatment group (Group B): 20 eligible patients were planned to be included and given sitagliptin 100mg Qd orally combined with Beidougen capsule 60mg Tid orally. The treatment period was 1 week.

Sitagliptin combined with Beidougen capsule treatment group (Group B)

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 aged 18-65 years with a first diagnosis of type 2 diabetes
• Diagnostic criteria 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, 100020, China

RECRUITING

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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Chao Yang Hospital

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: December 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

CN (1)