The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02366377

Enrollment

168

Registered

2015-02-19

Start date

2015-02-28

Completion date

Unknown

Last updated

2015-02-19

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 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.

Interventions

DRUGSHR3824

DRUGPlacebo

DRUGMetformin

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; * 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.

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 12
The number of volunteers with adverse events as a measure of safety and tolerability	Baseline to Week 12

Secondary

Measure	Time frame
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

Outcome results

None listed

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