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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: SHR3824
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SHR3824 Type 2 diabetes mellitus SGLT2