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

Phase 4

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Mulberry Twig Alkaloid Tablet; Drug: Canagliflozin

• Registration Number: NCT05856578
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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

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 Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-15
• Status Verified: 2023-01
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mulberry Twig Alkaloid Tablet	Mulberry Twig Alkaloid Tablet	Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet
Canagliflozin	Canagliflozin	Canagliflozin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Jianhua Ma; 🇨🇳 Nanjing, China