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

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University
• Treatments: Canagliflozin; Hypoglycemic Agents

Criteria

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.