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Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05667220
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Efficacy of Combination Therapy With Sitagliptin and Beidougen Capsule in Chinese Patients With Type 2 Diabetes
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Fasting blood glucose change [Changes in fasting blood glucose from baseline to 1 week treatment]

    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

  1. Serum GLP-1 change [Changes in serum GLP-1 from baseline to 1 week treatment]

    The serum active GLP-1 contents were measured using an active GLP-1 assay kit (EZGLPHS-35K, Millipore) according to the specification.

  2. Fecal DPP4 activity change [Changes in fecal DPP4 activity from baseline to 1 week treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao-yang Hospital, Capital Medical University Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guang Wang, Beijing Chao Yang Hospital, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT05667220
Other Study ID Numbers:
  • 2022-Sitagliptin-Beidougen
First Posted:
Dec 28, 2022
Last Update Posted:
Jan 3, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sitagliptin Phosphate

Study Results

No Results Posted as of Jan 3, 2023