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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mulberry Twig Alkaloid Tablet
Canagliflozin
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet, Canagliflozin, Flash Glucose Monitoring (FGM)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jianhua Ma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mulberry Twig Alkaloid Tablet

Canagliflozin

Arm Description

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet

Canagliflozin

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 15, 2022
Last Updated
May 3, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05856578
Brief Title
Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes
Official Title
Nanjing Medical University, Nanjing First Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet, Canagliflozin, Flash Glucose Monitoring (FGM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mulberry Twig Alkaloid Tablet
Arm Type
Experimental
Arm Description
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet
Arm Title
Canagliflozin
Arm Type
Active Comparator
Arm Description
Canagliflozin
Intervention Type
Drug
Intervention Name(s)
Mulberry Twig Alkaloid Tablet
Other Intervention Name(s)
Based on the original hypoglycemic treatment
Intervention Description
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet 50mg po tid
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
Based on the original hypoglycemic treatment
Intervention Description
Canagliflozin 100mg po qd
Primary Outcome Measure Information:
Title
Concentration of FBG, PBG and HbA1c
Description
The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of FBG, PBG and HbA1c in patients with type 2 diabetes mellitus.
Time Frame
12 weeks
Title
Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Concentration of C-peptide, Insulin, glucagon and HOMA-IR
Description
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.
Time Frame
12 weeks
Title
Concentration of the TC, TG, LDL, HDL and FFA
Description
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.
Time Frame
12 weeks
Title
Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Fecal 16S rRNA gene sequencing
Description
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.
Time Frame
12 weeks
Title
Incidence of hypoglycemia
Description
The effect of Mulberry Twig Alkaloid Tablet and Canagliflozin on the incidence of hypoglycemia in patients with type 2 diabetes mellitus by FGM.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Jianhua Ma
City
Nanjing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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