Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-29 @ 1:41 AM
Study NCT ID:
NCT01969357
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-21', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change from baseline in HbA1c at 12 week', 'timeFrame': 'baseline, week 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels', 'timeFrame': 'week 12'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 4, 8 and 12', 'timeFrame': 'Baseline, Week 4, 8, 12'}, {'measure': 'Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 4 ,12', 'timeFrame': 'baseline, week 4 ,12'}, {'measure': 'Change from baseline in Homeostasis model assessment-beta(HOMA-β) at week 4,week12', 'timeFrame': 'baseline, week 4,12week'}, {'measure': 'Change From Baseline in lipid at Week 4, 8 and 12', 'timeFrame': 'baseline, week 4, 8, 12'}, {'measure': 'Change From Baseline in Body Weight at Week 4,8,12', 'timeFrame': 'baseline, Week 4, 8,12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sp2086', 'Phase II', 'monotherapy'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus\n* Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%\n* BMI 19\\~35 kg/m2\n\nExclusion Criteria:\n\n* Patient has history of type 1 diabetes mellitus\n* Patient has history of ketoacidosis\n* Patient has history of severe unconscious hypoglycemosis\n* Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis\n* Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical\n* Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg\n* Patient has severe liver or kidney disease,alanine aminotransferase \\>2×UNL, Aspartate Aminotransferase \\>2×upper normal limit(UNL)；total bilirubin \\>2×UNL； creatinine\\>1.5 mg/dL (Male,132.6μmol/L) ，\\>1.4 mg/dL(Female，123.8μmol/L)\n* Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery\n* Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )\n* Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on\n* Patient has history of malignancy\n* Patient has history of alcohol or drug abuse'}, 'identificationModule': {'nctId': 'NCT01969357', 'briefTitle': 'A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter Randomized, Double-blind, Placebo and Positive Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'HR-SP-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '50 mg SP2086', 'interventionNames': ['Drug: 50 mg SP2086']}, {'type': 'EXPERIMENTAL', 'label': '100 mg SP2086', 'interventionNames': ['Drug: 100 mg SP2086']}, {'type': 'EXPERIMENTAL', 'label': '200 mg SP2086', 'interventionNames': ['Drug: 200 mg SP2086']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100 mg Sitagliptin', 'interventionNames': ['Drug: 100 mg Sitagliptin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets(n=4),once daily for 84 days', 'armGroupLabels': ['Placebo']}, {'name': '50 mg SP2086', 'type': 'DRUG', 'description': 'Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days', 'armGroupLabels': ['50 mg SP2086']}, {'name': '100 mg SP2086', 'type': 'DRUG', 'description': 'Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days', 'armGroupLabels': ['100 mg SP2086']}, {'name': '200 mg SP2086', 'type': 'DRUG', 'description': 'Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days', 'armGroupLabels': ['200 mg SP2086']}, {'name': '100 mg Sitagliptin', 'type': 'DRUG', 'description': 'Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days', 'armGroupLabels': ['100 mg Sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Changyu Pan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}