Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02105792
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}, {'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'At Visit 1, a fasting blood sample (approximately 35 ml) will be collected for DNA extraction, and to measure for markers of the progression of diabetes or response to diabetes medication and for secondary markers that may predict response. A urine sample is also collected to measure for biomarkers.\n\nAt Visit 2 a fasting blood sample and urine sample will be collected to measure for markers of the response to diabetes medication and for secondary markers that may predict response.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2014-04-02', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to diabetes therapy', 'timeFrame': 'Up to 9 months from commencement of new therapy', 'description': 'The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes.'}], 'secondaryOutcomes': [{'measure': 'Collection of samples for analysis of potential biomarkers', 'timeFrame': 'within 9 months of recruitment date', 'description': 'To collect a set of DNA, serum and urine samples to allow analysis of potential genetic and non genetic biomarkers for drug response and diabetes progression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Type 2 diabetes', 'Diabetes therapy response', 'Diabetes progression'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.', 'detailedDescription': "PILOT Phase (March 2013 - Dec 2014) Participants will be recruited initially from 4 centres. Patients due to start second- and third-line Type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. Fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. Participants in Responders Arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. If a 3 month HbA1c has not been collected as part of routine clinical care, the research team will arrange this. Participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. This visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change.\n\nAll study documentation and sample materials will be distributed to sites from the Coordinating Centre. Sites will be expected to process and freeze samples and send them to the Chief Investigator's Central Laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response.\n\nPOST-PILOT Phase (Jan 2015 - Oct 2017) Subject to feasibility, interim analysis and continuation of funding from Medical Research Council (MRC), this study will continue for another 3 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve:\n\nGP Searches; Secondary Care Clinician Referral; Research Database Searches.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Demographics: Age 18-90 inclusive\n* Ethnicity: Reflective of local demographic\n* Medical History: Clinical diagnosis of Type 2 diabetes\n* Mental Capacity: Capacity to Consent\n\nExclusion Criteria:\n\n* Age less than 18 years old and greater than 90 years old\n* Incapacity to consent\n* Type 1 diabetes.'}, 'identificationModule': {'nctId': 'NCT02105792', 'acronym': 'PROMASTER', 'briefTitle': 'PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes', 'orgStudyIdInfo': {'id': 'CRF112'}, 'secondaryIdInfos': [{'id': '12/SW/0347', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Responders', 'description': 'Patients with Type 2 diabetes about to commence a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors or Glitazone or insulin).', 'interventionNames': ['Drug: second- or third-line glucose-lowering diabetes treatment']}, {'label': 'Progressors', 'description': 'Patients with Type 2 diabetes that progress to requiring insulin treatment ≤10 years from diagnosis or have no requirement for insulin treatment \\>10 years from diagnosis.'}], 'interventions': [{'name': 'second- or third-line glucose-lowering diabetes treatment', 'type': 'DRUG', 'otherNames': ['Sulphonylurea', 'DPP-4 inhibitor', 'GLP-1R agonist', 'SGLT2 inhibitor', 'Glitazone'], 'description': "Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.", 'armGroupLabels': ['Responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'NE1 7RU', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'University of Newcastle', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'G12 8TA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE1 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College University of London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Andrew T Hattersley, FRCP, DM, BM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Exeter', 'class': 'OTHER'}, {'name': "King's College London", 'class': 'OTHER'}, {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, {'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, {'name': 'Newcastle University', 'class': 'OTHER'}, {'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}