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

Nanjing Medical University

Status and phase

Active, not recruiting

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Mulberry Twig Alkaloid Tablet

Drug: Canagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT05856578

KY20220124-03

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.