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

NCT ID: NCT05856578

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mulberry Twig Alkaloid Tablet

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet

Group Type EXPERIMENTAL

Mulberry Twig Alkaloid Tablet

Intervention Type DRUG

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

Canagliflozin

Canagliflozin

Group Type ACTIVE_COMPARATOR

Canagliflozin

Intervention Type DRUG

Canagliflozin 100mg po qd

Interventions

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Mulberry Twig Alkaloid Tablet

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

Intervention Type DRUG

Canagliflozin

Canagliflozin 100mg po qd

Intervention Type DRUG

Other Intervention Names

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Based on the original hypoglycemic treatment Based on the original hypoglycemic treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianhua Ma

Role: STUDY_DIRECTOR

Nanjing First Hospital, Nanjing Medical University

Locations

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Jianhua Ma

Nanjing, , China

Site Status

Countries

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China

Other Identifiers

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KY20220124-03

Identifier Type: -

Identifier Source: org_study_id

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