Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 as Monotherapy in in Chinese Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03159052

Enrollment

450

Registered

2017-05-18

Start date

2017-06-30

Completion date

2019-06-30

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24 weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.

Interventions

DRUGSHR3824

Once daily, 52 weeks

DRUGPlacebo

Once daily, 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients must have a diagnosis of type 2 diabetes mellitus; * Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 8 weeks; * FPG\<=15mmol/L; * Hemoglobin A1c levels \>=7.0% and \<=10.5%; * Body mass index (BMI) 19 to 35 kg/m2;

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame
Adjusted Mean Change in HbA1c Levels	Baseline to Week 24
The number of volunteers with adverse events as a measure of safety	Baseline to Week 52

Secondary

Measure	Time frame
Adjusted Mean Change in Fasting Plasma Glucose	Baseline to Week 24

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026