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

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT02346175

SHR3824-103

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Cohort1

Experimental group

Description:

5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort2

Experimental group

Description:

10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort3

Experimental group

Description:

20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.

Treatment:

Drug: Placebo

Drug: SHR3824