Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
NCT ID: NCT02346175
Last Updated: 2015-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2014-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort1
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
SHR3824
Placebo
Cohort2
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
SHR3824
Placebo
Cohort3
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
SHR3824
Placebo
Interventions
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SHR3824
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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SHR3824-103
Identifier Type: -
Identifier Source: org_study_id
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