NCT02366377

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

February 12, 2015

Last Update Submit

February 18, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Adjusted Mean Change in HbA1c Levels

    Baseline to Week 12

  • The number of volunteers with adverse events as a measure of safety and tolerability

    Baseline to Week 12

Secondary Outcomes (2)

  • Adjusted Mean Change in Fasting Plasma Glucose

    Baseline to Week 12

  • Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

    Baseline to Week 12

Study Arms (4)

SHR3824 Placebo

EXPERIMENTAL

SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Drug: PlaceboDrug: Metformin

SHR3824 5 mg

EXPERIMENTAL

SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Drug: SHR3824Drug: Metformin

SHR3824 10 mg

EXPERIMENTAL

SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Drug: SHR3824Drug: Metformin

SHR3824 20 mg

EXPERIMENTAL

SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.

Drug: SHR3824Drug: Metformin

Interventions

SHR3824DRUG
SHR3824 10 mgSHR3824 20 mgSHR3824 5 mg
PlaceboDRUG
SHR3824 Placebo
MetforminDRUG
SHR3824 10 mgSHR3824 20 mgSHR3824 5 mgSHR3824 Placebo

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;
  • Hemoglobin A1c levels \>=7.5% and \<=10.5%;
  • Body mass index (BMI) 25 to 45 kg/m2;
  • Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

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

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

Study Design

Study Type
interventional
Phase
phase 1
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

February 12, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Last Updated

February 19, 2015

Record last verified: 2015-02