Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-05 @ 2:09 AM
Study NCT ID:
NCT02822534
Status:
UNKNOWN
Last Update Posted:
2016-07-04
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum plasma concentration (Cmax) of SP2086', 'timeFrame': 'up to Day 13', 'description': "Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086"}, {'measure': 'The steady-state plasma concentration (Css) of SP2086', 'timeFrame': 'up to Day 13', 'description': "Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086"}, {'measure': 'The maximum plasma concentration (Cmax) of SP2086 acid', 'timeFrame': 'up to Day 13', 'description': "Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086"}, {'measure': 'The steady-state plasma concentration (Css) of SP2086 acid', 'timeFrame': 'up to Day 13', 'description': "Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086"}, {'measure': 'The maximum urine concentration (Cmax) of SP2086', 'timeFrame': 'up to Day 13', 'description': "Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086"}, {'measure': 'The steady-state urine concentration (Css) of SP2086', 'timeFrame': 'up to Day 13', 'description': "Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086"}, {'measure': 'The maximum urine concentration (Cmax) of SP2086 acid', 'timeFrame': 'up to Day 13', 'description': "Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086"}, {'measure': 'The steady-state urine concentration (Css) of SP2086 acid', 'timeFrame': 'up to Day 13', 'description': "Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086"}], 'secondaryOutcomes': [{'measure': 'The number of volunteers with adverse events as a measure of safety and tolerability', 'timeFrame': 'up to Day 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SP2086 in Type 2 Diabetes Patients .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient has a definitive diagnosis of Type 2 Diabetes.\n* BMI(a measure of a person's weight in relation to height)is between 19 and 30 kg/m2,and the weight is equal or greater than 50kg.\n* Never use the antidiabetic or only use one type oral antidiabetic(except the insulin secretagogues agent).\n* The patient never use insulin in 3 months of screening.\n* Be willing to accept physical contraception.\n* Sign the informed consents voluntarily and ensure to completed the study.\n\nExclusion Criteria:\n\n* The value of fasting blood-glucose(FBG)\\>13.9mmol/L,or HbA1c\\>10.0%;\n* Known allergy to SP2086 or any of the excipients of the formulation of SP2086;\n* Type 1 diabetes,or Gestational diabetes,or other type diabetes;\n* ever occured acute complications of diabetes such as diabetic ketoacidosis,high permeability syndrome or lactic acidosis.\n* ever occured the severe hypoglycemia.\n* History of chronic complication of diabetes(kidney disease,or retinopathy,neuropathy,or lower limb vascular lesion).\n* The value of serum creatinine over the upper limit of normal range.\n* ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.\n* QTc interval\\>450ms(male) or \\>470ms(female) or have the history of cardiac insufficiency which the NYHA(New York Heart Association) class over I degree.\n* have the history of hypertension,and not well control:SBP(Systolic Blood Pressure)\\>140 mmHg or DBP(Diastolic Blood Pressure)\\>90 mmHg.\n* have the history of cancer.\n* the value of ALT and/or AST was greater two times of upper limit of normal range,or the STB over the 1.5 times of upper limit of normal range.\n* the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.\n* had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.\n* have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.\n* have the history of tobacco,alcohol or drug abuse.\n* History of or current clinically significant medical illness as determined by the Investigator."}, 'identificationModule': {'nctId': 'NCT02822534', 'briefTitle': 'The Pharmacokinetics and Pharmacodynamics Study of Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'the Pharmacokinetics,Pharmacodynamics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'SP2086-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SP2086 50mg', 'description': 'there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.', 'interventionNames': ['Drug: SP2086']}, {'type': 'EXPERIMENTAL', 'label': 'SP2086 100mg', 'description': 'there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.', 'interventionNames': ['Drug: SP2086']}, {'type': 'EXPERIMENTAL', 'label': 'SP2086 200mg', 'description': 'there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 8 Type 2 diabetes patients.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.', 'interventionNames': ['Drug: SP2086']}], 'interventions': [{'name': 'SP2086', 'type': 'DRUG', 'description': 'the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.', 'armGroupLabels': ['SP2086 100mg', 'SP2086 200mg', 'SP2086 50mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanhua Ding, docter', 'role': 'CONTACT', 'email': 'dingyanhua2003@126.com', 'phone': '0431-88782168'}], 'facility': 'the First Hosital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Yanhua Ding, docter', 'role': 'CONTACT', 'email': 'dingyanhua2003@126.com', 'phone': '0431-88782168'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}