NCT04390295

Brief Summary

The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.

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
450

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_3 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

November 2, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2.5 years

First QC Date

September 18, 2018

Last Update Submit

May 14, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Adjusted Mean Change in HbA1c Levels

    Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group

    Baseline to Week 24

Secondary Outcomes (2)

  • Adjusted Mean Change in Fasting Plasma Glucose

    Baseline to Week 24

  • The number of volunteers with adverse events as a measurement of safety

    Baseline to Week 52

Study Arms (3)

SHR3824+Metformin, Placebo+Metformin

EXPERIMENTAL

once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks

Drug: Placebo

SHR3824 5 mg+Metformin

EXPERIMENTAL

once daily for SHR3824, three times daily for metformin, 52 weeks

Drug: SHR3824Drug: metformin

SHR3824 10 mg+Metformin

EXPERIMENTAL

once daily for SHR3824, three times daily for metformin, 52 weeks

Drug: SHR3824Drug: metformin

Interventions

PlaceboDRUG

Once daily, 24 weeks

SHR3824+Metformin, Placebo+Metformin
SHR3824DRUG

Once daily, 52 weeks

SHR3824 10 mg+MetforminSHR3824 5 mg+Metformin
metforminDRUG

Three times daily, 52 weeks

SHR3824 10 mg+MetforminSHR3824 5 mg+Metformin

Eligibility Criteria

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

You may qualify if:

  • Patients must have a diagnosis of type 2 diabetes mellitus;
  • Patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day;
  • FPG\<=15mmol/L;
  • Hemoglobin A1c levels \>=7.0% and \<=10.5%;
  • Body mass index (BMI) 19 to 35 kg/m2;

You may not qualify if:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
  • Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
  • Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
  • History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
  • Past or current history of malignant tumor;
  • Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
  • Pregnant women, lactating mothers, or women of childbearing potential;
  • Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affiliated Hospital of Sun Yat - sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

WENG Jianping, professor

CONTACT

86-020-85250217wjianp@mail.sysu.edu.cn

CHEN Jianwen, professor

CONTACT

18036611985chenjianwen@hrglobe.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

May 15, 2020

Study Start

November 2, 2017

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

CN(1)