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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: SHR3824; Drug: Placebo

• Registration Number: NCT02346175
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-26
• Last Update Submitted: 2015-02-01
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort1	Placebo	5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Cohort2	SHR3824	10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Cohort3	Placebo	20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Cohort3	SHR3824	20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Cohort2	Placebo	10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Cohort1	SHR3824	5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Primary Outcome Measures

Name	Time	Method
Urine glucose concentration of SHR3824	up to Day 11
Plasma pharmacokinetic parameters of SHR3824	up to Day 13
Plasma glucose concentration of SHR3824	up to Day 11

Secondary Outcome Measures

Name	Time	Method
The number and type of adverse events reported	Up to Day 13