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Clinical Trial Details

Trial ID: L6535
Source ID: NCT05856578
Associated Drug: Mulberry Twig Alkaloid Tablet
Title: Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Mulberry Twig Alkaloid Tablet|DRUG: Canagliflozin
Outcome Measures: 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|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|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|Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α, 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., 12 weeks | 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|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
Sponsor/Collaborators: Sponsor: Nanjing First Hospital, Nanjing Medical University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-03-15
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2023-05-12
Locations: Jianhua Ma, Nanjing, China
URL: https://clinicaltrials.gov/show/NCT05856578