Type 2 Diabetes Mellitus
Conditions
Keywords
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet, Canagliflozin, Flash Glucose Monitoring （FGM）
Brief summary
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
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.
Interventions
DRUGMulberry Twig Alkaloid Tablet
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid
DRUGCanagliflozin
Canagliflozin 100mg po qd
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of FBG, PBG and HbA1c | 12 weeks | The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of FBG, PBG and HbA1c in patients with type 2 diabetes mellitus. |
| Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α | 12 weeks | 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. |
| Concentration of the TC, TG, LDL, HDL and FFA | 12 weeks | 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. |
| Concentration of C-peptide, Insulin, glucagon and HOMA-IR | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal 16S rRNA gene sequencing | 12 weeks | 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. |
| Incidence of hypoglycemia | 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. |
Countries
China
Outcome results
None listed