Back to resultsPharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SHR3824
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring SHR3824 Type 2 diabetes mellitus SGLT2
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort1
Cohort2
Cohort3
Arm Description
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Outcomes
Primary Outcome Measures
Plasma pharmacokinetic parameters of SHR3824
Urine glucose concentration of SHR3824
Plasma glucose concentration of SHR3824
Secondary Outcome Measures
The number and type of adverse events reported
Full Information
NCT ID
NCT02346175
First Posted
January 20, 2015
Last Updated
February 1, 2015
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02346175
Brief Title
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Official Title
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
SHR3824 Type 2 diabetes mellitus SGLT2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort1
Arm Type
Experimental
Arm Description
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Arm Title
Cohort2
Arm Type
Experimental
Arm Description
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Arm Title
Cohort3
Arm Type
Experimental
Arm Description
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Intervention Type
Drug
Intervention Name(s)
SHR3824
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Plasma pharmacokinetic parameters of SHR3824
Time Frame
up to Day 13
Title
Urine glucose concentration of SHR3824
Time Frame
up to Day 11
Title
Plasma glucose concentration of SHR3824
Time Frame
up to Day 11
Secondary Outcome Measure Information:
Title
The number and type of adverse events reported
Time Frame
Up to Day 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
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