Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Sitagliptin combined with Beidougen capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin monotherapy group (Group A)<br> | Drug: Sitagliptin<br>* 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.<br>|
| Experimental: Sitagliptin combined with Beidougen capsule treatment group (Group B)<br> | Drug: Sitagliptin combined with Beidougen capsule<br>* 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.<br>|

What is the study measuring?
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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 |