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

May 3, 2023 updated by: Nanjing First Hospital, Nanjing Medical University

Nanjing Medical University, Nanjing First Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China
        • Jianhua Ma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Drug: Canagliflozin
Canagliflozin 100mg po qd
Other Names:
  • Based on the original hypoglycemic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of FBG, PBG and HbA1c
Time Frame: 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.
12 weeks
Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of C-peptide, Insulin, glucagon and HOMA-IR
Time Frame: 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.
12 weeks
Concentration of the TC, TG, LDL, HDL and FFA
Time Frame: 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.
12 weeks
Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α
Time Frame: 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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal 16S rRNA gene sequencing
Time Frame: 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.
12 weeks
Incidence of hypoglycemia
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: Jianhua Ma, Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20220124-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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