Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single and multiple oral doses of 5mg to 20 mg SHR3824 in Type 2 diabetes mellitus patients.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: SHR3824

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI:20-35kg/m2;
• Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
• On a stable regimen of antihyperglycemic therapy for at least 8 weeks prior to screening and had fasting plasma glucose (FPG) concentration lower than 13.9 mmol/L at baseline;
• Stable antihyperglycemic regimens could include a single oral agent (eg, metformin, a sulfonylurea, a thiazolidinediones ketone, a benzoic acid derivatives, a dipeptidyl peptidase-4 inhibitor, or an α-glucosidase inhibitor) with glycated hemoglobin (HbA1c) between 7.0% and 10.0%.

Exclusion Criteria:

• History of clinically significant diabetic complications, type 1 diabetes mellitus, or repeated severe hypoglycemic episodes.
• Pregnancy or breastfeeding;
• Significant acute or chronic medical illness, including renal impairment, or recent surgery;
• Donation of blood or plasma within the 4 weeks prior to the start of the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort1; 5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.	Drug: Placebo; Drug: SHR3824
Experimental: Cohort2; 10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.	Drug: Placebo; Drug: SHR3824
Experimental: Cohort3; 20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.	Drug: Placebo; Drug: SHR3824

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma pharmacokinetic parameters of SHR3824	up to Day 13
Urine glucose concentration of SHR3824	up to Day 11
Plasma glucose concentration of SHR3824	up to Day 11

Secondary Outcome Measures

Outcome Measure	Time Frame
The number and type of adverse events reported	Up to Day 13

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: February 1, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SHR3824-103