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

Sponsor

Nanjing First Hospital, Nanjing Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05856578

Collaborator

(none)

Enrollment

Location

Arms

21.6

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Mulberry Twig Alkaloid Tablet Drug: Canagliflozin	Phase 4

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

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Nanjing Medical University, Nanjing First Hospital

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mulberry Twig Alkaloid Tablet Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet	Drug: Mulberry Twig Alkaloid Tablet Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid Other Names: Based on the original hypoglycemic treatment
Active Comparator: Canagliflozin Canagliflozin	Drug: Canagliflozin Canagliflozin 100mg po qd Other Names: Based on the original hypoglycemic treatment

Arm

Intervention/Treatment

Experimental: Mulberry Twig Alkaloid Tablet

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet

Drug: Mulberry Twig Alkaloid Tablet

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid

Other Names:

Based on the original hypoglycemic treatment

Active Comparator: Canagliflozin

Canagliflozin

Drug: Canagliflozin

Canagliflozin 100mg po qd

Other Names:

Based on the original hypoglycemic treatment

Outcome Measures

Primary Outcome Measures

Concentration of FBG, PBG and HbA1c [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 [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 Outcome Measures

Concentration of C-peptide, Insulin, glucagon and HOMA-IR [12 weeks]
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.
Concentration of the TC, TG, LDL, HDL and FFA [12 weeks]
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.
Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α [12 weeks]
The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of inflammatory factor(including adiponectin,leptin,IL-1,IL-6,TNF-α) changes in patients with type 2 diabetes mellitus.

Other Outcome Measures

Fecal 16S rRNA gene sequencing [12 weeks]
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.
Incidence of hypoglycemia [12 weeks]
The effect of Mulberry Twig Alkaloid Tablet and Canagliflozin on the incidence of hypoglycemia in patients with type 2 diabetes mellitus by FGM.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.