Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667220
• Other study ID #: 2022-Sitagliptin-Beidougen
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Beijing Chao Yang Hospital
• Contact: Jia Liu, MD
• Phone: 010-85231710
• Email: liujia0116[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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