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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mulberry Twig Alkaloid Tablet | Experimental | Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet |
|
| Canagliflozin | Active Comparator | Canagliflozin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mulberry Twig Alkaloid Tablet | Drug | Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal 16S rRNA gene sequencing | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on types of intestinal flora changes in patients with type 2 diabetes mellitus by Fecal 16S rRNA gene sequencing. | 12 weeks |
| Incidence of hypoglycemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhua Ma | Nanjing First Hospital, Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianhua Ma | Nanjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42014890 | Derived | Li H, Tao S, Zhou X, Yan R, Yu B, Luo Y, Zhang P, Kong X, Ma J. Effects of mulberry twig alkaloids and canagliflozin in inadequately controlled type 2 diabetes: a randomized controlled study based on flash glucose monitoring. Sci Rep. 2026 Apr 21;16(1):18502. doi: 10.1038/s41598-026-48843-2. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Canagliflozin | Drug | Canagliflozin 100mg po qd |
|
|
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 |
The effect of Mulberry Twig Alkaloid Tablet and Canagliflozin on the incidence of hypoglycemia in patients with type 2 diabetes mellitus by FGM.
| 12 weeks |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |