Nanjing Medical University, Nanjing First Hospital

KY20220124-03

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

2022-03-15

2023-05-31

2023-12-31

Active (not recruiting)

Early phase I

60

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-05-12