Nanjing Medical University, Nanjing First Hospital
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Concentration of FBG, PBG and HbA1c
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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/m
- •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.
Arms & Interventions
Mulberry Twig Alkaloid Tablet
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet
Intervention: Mulberry Twig Alkaloid Tablet (Drug)
Canagliflozin
Canagliflozin
Intervention: Canagliflozin (Drug)
Outcomes
Primary Outcomes
Concentration of FBG, PBG and HbA1c
Time Frame: 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
Time Frame: 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 Outcomes
- Concentration of C-peptide, Insulin, glucagon and HOMA-IR(12 weeks)
- Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α(12 weeks)
- Concentration of the TC, TG, LDL, HDL and FFA(12 weeks)