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The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT02366377
Recruitment Status : Unknown
Verified February 2015 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Study Start Date : February 2015
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHR3824 Placebo
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Drug: Placebo
Drug: Metformin
Experimental: SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Drug: SHR3824
Drug: Metformin
Experimental: SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Drug: SHR3824
Drug: Metformin
Experimental: SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Drug: SHR3824
Drug: Metformin



Primary Outcome Measures :
  1. Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 12 ]
  2. The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Adjusted Mean Change in Fasting Plasma Glucose [ Time Frame: Baseline to Week 12 ]
  2. Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% [ Time Frame: Baseline to Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a diagnosis of type 2 diabetes mellitus;
  • Hemoglobin A1c levels >=7.5% and <=10.5%;
  • Body mass index (BMI) 25 to 45 kg/m2;
  • Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.

Exclusion Criteria:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
  • Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
  • Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
  • History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
  • Past or current history of malignant tumor;
  • Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
  • Pregnant women, lactating mothers, or women of childbearing potential;
  • Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02366377    
Other Study ID Numbers: SHR3824-108
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs