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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02366377
• Other study ID #: SHR3824-108
• Status: Not yet recruiting
• Phase: Phase 1
• First received: February 12, 2015
• Last updated: February 18, 2015
• Start date: February 2015

Study information

• Verified date: February 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SHR3824

• Placebo

• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c Levels		Baseline to Week 12	No
Primary	The number of volunteers with adverse events as a measure of safety and tolerability		Baseline to Week 12	Yes
Secondary	Adjusted Mean Change in Fasting Plasma Glucose		Baseline to Week 12	No
Secondary	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%		Baseline to Week 12	No