Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 8:58 PM
Study NCT ID:
NCT00916604
Status:
COMPLETED
Last Update Posted:
2009-11-03
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576407', 'term': 'AZD1656'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-02', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG', 'timeFrame': 'Blood samples taken repeatedly during 24 hours on study day sessions'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).', 'timeFrame': 'Blood samples taken repeatedly during 24 hours on study day sessions'}, {'measure': 'Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).', 'timeFrame': 'Blood samples taken repeatedly during 24 hours on study day sessions'}]}, 'conditionsModule': {'keywords': ['AZD1656', 'Safety', 'Pharmacokinetics', 'Pharmacodynamic', 'Multiple ascending doses', 'Japanese', 'T2DM'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.\n* A body mass index (BMI) of 19 to 27 kg/m2.\n* Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* Renal dysfunction GFR \\< 60 mL/min.\n* Systolic pressure (SBP) \\> 160 mmHg or diastolic pressure (DBP) \\> 95 mmHg\n* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.\n* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.'}, 'identificationModule': {'nctId': 'NCT00916604', 'acronym': 'JMAD', 'briefTitle': 'To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients', 'orgStudyIdInfo': {'id': 'D1020C00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)', 'interventionNames': ['Drug: AZD1656']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo oral suspension given to 3 groups (2 on placebo in each group)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1656', 'type': 'DRUG', 'description': 'Three increasing dose-steps with oral suspension, 8 days treatment', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral suspension, 8 days treatment', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Klas Malmberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Mölndal'}, {'name': 'Takashi Eto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PS Clinic, Fukuoka, Japan'}, {'name': 'Mitsuyasu Hokamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HONJO CLINIC II, Tokyo, Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Klas Malmberg, MD, PhD, Prof, Medical Science Director', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}