Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The aim of the study is to investigate the efficacy and safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin for 12 weeks in individuals with type 2 diabetes mellitus

Detailed Description
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To compare the clinical efficacy, insulin resistance and blood glucose fluctuation of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin in patients with type 2 diabetes mellitus using FGMS.

Official Title
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Nanjing Medical University, Nanjing First Hospital

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Mulberry Twig Alkaloid Tablet
* Drug: Canagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate and be able to sign informed consent prior to the trial. Patients with type 2 diabetes, aged 18-75 years old and BMI ≥18.0kg/m2. Treatment with one or two hypoglycemic drugs (in combination, the sulfonylureas dose should be less than half of the maximum dose). HbA1c : 7.0-9.0%. Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. Exclusion Criteria: Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal. Recurrent urinary tract infections. Drug abuse and alcohol dependence in the past 5 years. Patients with poor compliance and irregular diet and exercise. Systemic hormone therapy was used in the last three months. Patients with infection and stress within four weeks. Patients with pregnancy, lactation or pregnancy intention. Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mulberry Twig Alkaloid Tablet<br>Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet | Drug: Mulberry Twig Alkaloid Tablet<br>* Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid<br>* Other names: Based on the original hypoglycemic treatment;|
| Active Comparator: Canagliflozin<br>Canagliflozin | Drug: Canagliflozin<br>* Canagliflozin 100mg po qd<br>* Other names: Based on the original hypoglycemic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of FBG, PBG and HbA1c | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of FBG, PBG and HbA1c in patients with type 2 diabetes mellitus. | 12 weeks | 
| Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the changes of blood glucose fluctuations (including MBG, TIR, TAR, TBR, MAGE, MBG and LAGE) in patients with type 2 diabetes mellitus by FGM. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of C-peptide, Insulin, glucagon and HOMA-IR | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on C-peptide, Insulin, glucagon and HOMA-IR changes in patients with type 2 diabetes mellitus. | 12 weeks | 
| Concentration of the TC, TG, LDL, HDL and FFA | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on concentration of blood lipid (including TC, TG, LDL, HDL, FFA) changes in patients with type 2 diabetes mellitus. | 12 weeks | 
| Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of inflammatory factor(including adiponectin,leptin,IL-1,IL-6,TNF-α) changes in patients with type 2 diabetes mellitus. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Canagliflozin, Flash Glucose Monitoring （FGM）, Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet