Back to resultsSitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sitagliptin
Sitagliptin combined with Beidougen capsule
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Beijing Chao-yang Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sitagliptin monotherapy group (Group A)
Sitagliptin combined with Beidougen capsule treatment group (Group B)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05667220
First Posted
December 19, 2022
Last Updated
December 29, 2022
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05667220
Brief Title
Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
Official Title
Efficacy of Combination Therapy With Sitagliptin and Beidougen Capsule in Chinese Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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
5. Study Description
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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin monotherapy group (Group A)
Arm Type
Active Comparator
Arm Title
Sitagliptin combined with Beidougen capsule treatment group (Group B)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin combined with Beidougen capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting blood glucose change
Description
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.
Time Frame
Changes in fasting blood glucose from baseline to 1 week treatment
Secondary Outcome Measure Information:
Title
Serum GLP-1 change
Description
The serum active GLP-1 contents were measured using an active GLP-1 assay kit (EZGLPHS-35K, Millipore) according to the specification.
Time Frame
Changes in serum GLP-1 from baseline to 1 week treatment
Title
Fecal DPP4 activity change
Description
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.
Time Frame
Changes in fecal DPP4 activity from baseline to 1 week treatment
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 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
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
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Liu, MD
Phone
010-8523161710
Email
liujia0116@126.com
12. IPD Sharing Statement
Learn more about this trial
Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
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