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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Nanjing Medical University, Nanjing First Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05856578
• Other study ID #: KY20220124-03
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Mulberry Twig Alkaloid Tablet
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid
• Canagliflozin
Canagliflozin 100mg po qd

Locations

Country	Name	City	State
China	Jianhua Ma	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal 16S rRNA gene sequencing	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.	12 weeks
Other	Incidence of hypoglycemia	The effect of Mulberry Twig Alkaloid Tablet and Canagliflozin on the incidence of hypoglycemia in patients with type 2 diabetes mellitus by FGM.	12 weeks
Primary	Concentration of FBG, PBG and HbA1c	The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of FBG, PBG and HbA1c in patients with type 2 diabetes mellitus.	12 weeks
Primary	Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE	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.	12 weeks
Secondary	Concentration of C-peptide, Insulin, glucagon and HOMA-IR	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.	12 weeks
Secondary	Concentration of the TC, TG, LDL, HDL and FFA	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.	12 weeks
Secondary	Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-a	The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of inflammatory factor(including adiponectin,leptin,IL-1,IL-6,TNF-a) changes in patients with type 2 diabetes mellitus.	12 weeks