NCT05856578

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

March 15, 2022

Last Update Submit

May 3, 2023

Conditions

Type 2 Diabetes Mellitus

Keywords

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid TabletCanagliflozinFlash Glucose Monitoring （FGM）

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Concentration of C-peptide, Insulin, glucagon and HOMA-IR

    12 weeks

  • Concentration of the TC, TG, LDL, HDL and FFA

    12 weeks

  • Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α

    12 weeks

Other Outcomes (2)

  • Fecal 16S rRNA gene sequencing

    12 weeks

  • Incidence of hypoglycemia

    12 weeks

Study Arms (2)

Mulberry Twig Alkaloid Tablet

EXPERIMENTAL

Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet

Drug: Mulberry Twig Alkaloid Tablet

Canagliflozin

ACTIVE COMPARATOR

Canagliflozin

Drug: Canagliflozin

Interventions

Mulberry Twig Alkaloid TabletDRUG

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

Also known as: Based on the original hypoglycemic treatment
Mulberry Twig Alkaloid Tablet
CanagliflozinDRUG

Canagliflozin 100mg po qd

Also known as: Based on the original hypoglycemic treatment
Canagliflozin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianhua Ma

Nanjing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Jianhua Ma

    Nanjing First Hospital, Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

May 12, 2023

Study Start

March 15, 2022

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

May 12, 2023

Record last verified: 2023-01

Locations

CN(1)