Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

Efficacy of Combination Therapy With Sitagliptin and Beidougen Capsule in Chinese Patients With Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Sitagliptin; Drug: Sitagliptin combined with Beidougen capsule

• Study Type: Interventional
• Enrollment (Anticipated): 20
• 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, 100020
      • Recruiting
      • Beijing Chao-yang Hospital, Capital Medical University
      • Contact: Jia Liu, MD; Phone Number: 010-8523161710; Email: liujia0116@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients aged 18-65 years with a first diagnosis of type 2 diabetes
• Diagnostic criteria 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sitagliptin monotherapy group (Group A)	Drug: Sitagliptin; 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.
Experimental: Sitagliptin combined with Beidougen capsule treatment group (Group B)	Drug: Sitagliptin combined with Beidougen capsule; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum GLP-1 change	The serum active GLP-1 contents were measured using an active GLP-1 assay kit (EZGLPHS-35K, Millipore) according to the specification.	Changes in serum GLP-1 from baseline to 1 week treatment
Fecal DPP4 activity change	For measurement of fecal DPP4 activity, 60 mg feces were homogenized in RIPA lysis buffer (with final concentration at 1 mg/mL) was added to 50 mM sodium phosphate buffer (pH = 7.4, OD600 = 0.5), and the reaction was started by the addition of 250 μM H-A-pNA. After incubation for 30 min at 37 °C, the absorbance was measured at 405 nm.	Changes in fecal DPP4 activity from baseline to 1 week treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

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: 2022-Sitagliptin-Beidougen

Drug and device information, study documents

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