Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01970033
Status:
UNKNOWN
Last Update Posted:
2013-10-25
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SP2086 as Monotherapy in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-22', 'studyFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week24', 'timeFrame': 'baseline, week 24', 'description': 'A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in fasting plasma glucose (FPG) at Week 24', 'timeFrame': 'Weeks 0-24', 'description': 'Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG'}, {'measure': 'Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24', 'timeFrame': 'Weeks 0-24', 'description': 'Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG'}, {'measure': 'Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels', 'timeFrame': 'week24'}, {'measure': 'Change From Baseline in A1C at Week 52', 'timeFrame': 'week 52', 'description': 'A1C is measured as a percent. Thus, this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent'}, {'measure': 'Change From Baseline in FPG at Week 52', 'timeFrame': 'week 52', 'description': 'Change from baseline at Week 52 is defined as Week 104 FPG minus Week 0 FPG'}, {'measure': 'Change From Baseline in lipid at Week 4、8、12、24、38、52', 'timeFrame': 'Week 4、8、12、24、38、52'}, {'measure': 'Change From Baseline in Body Weight at Week 4,8,12、24、38、52', 'timeFrame': 'Week 4、8、12、24、38、52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SP2086', 'Phase III', 'Monotherapy'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with type 2 diabetes mellitus\n* Patients have treated with diet/exercise at least 3 months\n* 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in\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': 'NCT01970033', 'briefTitle': 'Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase III Study to Access the Efficacy and Safety of SP2086 Treated Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'HR-SP2086-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SP2086 50 mg b.i.d', 'interventionNames': ['Drug: SP2086 50 mg b.i.d.']}, {'type': 'EXPERIMENTAL', 'label': 'SP2086 100 mg q.d.', 'interventionNames': ['Drug: SP2086 100 mg q.d.']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '* Run in period ：oral tablets of Placebo twice daily for 2 weeks\n* Phase A : oral tablets of Placebo twice daily for 24 weeks\n* Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'SP2086 50 mg b.i.d.', 'type': 'DRUG', 'description': '* Run-in period: placebo twice daily for 2 weeks\n* Phase A:SP2086 50 mg b.i.d for 24 weeks\n* Phase B:SP2086 50 mg b.i.d for 28 weeks', 'armGroupLabels': ['SP2086 50 mg b.i.d']}, {'name': 'SP2086 100 mg q.d.', 'type': 'DRUG', 'description': '* Run-in period:placebo twice daily for 2 weeks\n* Phase A: SP2086 100 mg q.d. for 24 weeks\n* Phase B: SP2086 100 mg q.d. for 28 weeks', 'armGroupLabels': ['SP2086 100 mg q.d.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changyu Pan, M.D.', 'role': 'CONTACT', 'email': 'panchy301@aliyun.com'}, {'name': 'Changyu Pan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Changyu Pan, M.D.', 'role': 'CONTACT', 'email': 'panchy301@aliyun.com', 'phone': '86 10 66887329'}, {'name': 'Huaqiong Shen, P.H.D', 'role': 'CONTACT', 'email': 'shenhuaqiong@hrs.com.cn', 'phone': '86 21 68868570', 'phoneExt': '827'}], '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'}}}}