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

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ClinicalTrials.gov Identifier: NCT02346175
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: SHR3824 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort1
5-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Drug: SHR3824
Drug: Placebo
Experimental: Cohort2
10-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Drug: SHR3824
Drug: Placebo
Experimental: Cohort3
20-mg/day SHR3824 or placebo once daily on Day 1 and on Days 4 through 10.
Drug: SHR3824
Drug: Placebo



Primary Outcome Measures :
  1. Plasma pharmacokinetic parameters of SHR3824 [ Time Frame: up to Day 13 ]
  2. Urine glucose concentration of SHR3824 [ Time Frame: up to Day 11 ]
  3. Plasma glucose concentration of SHR3824 [ Time Frame: up to Day 11 ]

Secondary Outcome Measures :
  1. The number and type of adverse events reported [ Time Frame: Up to Day 13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02346175     History of Changes
Other Study ID Numbers: SHR3824-103
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR3824 Type 2 diabetes mellitus SGLT2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases