Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT00324350
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2006-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intensive Glycemic Control and Skeletal Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aschwartz@psg.ucsf.edu', 'phone': '415-514-8000', 'title': 'Dr. Ann Schwartz', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The initial identification of a possible fracture event relied on self-report at annual visits with the possibility of under- or over-reporting of fractures.'}}, 'adverseEventsModule': {'description': 'Adverse events were not collected as a part of this ACCORD-BONE ancillary study. Please refer to the ACCORD main study results for all adverse event results.', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Non-vertebral Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3655', 'groupId': 'OG000'}, {'value': '3632', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'OG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000', 'lowerLimit': '.86', 'upperLimit': '.127'}, {'value': '189', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.678', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.27', 'pValueComment': 'Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.', 'groupDescription': 'The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Average follow-up of 3.8 years', 'description': 'The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Fall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3364', 'groupId': 'OG000'}, {'value': '3418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'OG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}], 'classes': [{'categories': [{'measurements': [{'value': '1122', 'groupId': 'OG000'}, {'value': '1133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.43', 'groupDescription': 'Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Average follow-up of 2.0 years', 'description': 'At each annual visit starting in January 2006, participants were also asked about falling: "In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?" Those who answered "yes" were also asked how many times they had fallen in the previous 12 months.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With > 2 cm of Height Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3482', 'groupId': 'OG000'}, {'value': '3497', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'OG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}], 'classes': [{'categories': [{'measurements': [{'value': '678', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.11', 'estimateComment': 'The rate of height loss did not differ between groups (p = 0.573). Height loss of \\>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).', 'groupDescription': 'Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \\>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing \\>2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'FG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3655'}, {'groupId': 'FG001', 'numSubjects': '3632'}]}, {'type': 'Non-Vertebral Fracture Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3655'}, {'groupId': 'FG001', 'numSubjects': '3632'}]}, {'type': 'Falls Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3364'}, {'groupId': 'FG001', 'numSubjects': '3418'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3655'}, {'groupId': 'FG001', 'numSubjects': '3632'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The ACCORD trial has been described previously (Buse JB,et al. Am J Cardiol 99:21i-33i, 2007). Five of the 7 clinical center networks agreed to participate in the BONE ancillary study, including 54 of 77 clinical sites and 7,287 participants. The BONE ancillary study was initiated during the main recruitment for ACCORD (beginning in 2006).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3655', 'groupId': 'BG000'}, {'value': '3632', 'groupId': 'BG001'}, {'value': '7287', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Glycemic Control', 'description': 'intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'BG001', 'title': 'Standard Glycemic Control', 'description': 'standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2380', 'groupId': 'BG000'}, {'value': '2361', 'groupId': 'BG001'}, {'value': '4741', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1275', 'groupId': 'BG000'}, {'value': '1271', 'groupId': 'BG001'}, {'value': '2546', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1267', 'groupId': 'BG000'}, {'value': '1251', 'groupId': 'BG001'}, {'value': '2518', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2388', 'groupId': 'BG000'}, {'value': '2381', 'groupId': 'BG001'}, {'value': '4769', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2903', 'groupId': 'BG000'}, {'value': '2876', 'groupId': 'BG001'}, {'value': '5779', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '752', 'groupId': 'BG000'}, {'value': '756', 'groupId': 'BG001'}, {'value': '1508', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2006-05-10', 'resultsFirstSubmitDate': '2012-03-15', 'studyFirstSubmitQcDate': '2006-05-10', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-05', 'studyFirstPostDateStruct': {'date': '2006-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least One Non-vertebral Fracture', 'timeFrame': 'Average follow-up of 3.8 years', 'description': 'The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.'}, {'measure': 'Number of Participants With at Least One Fall', 'timeFrame': 'Average follow-up of 2.0 years', 'description': 'At each annual visit starting in January 2006, participants were also asked about falling: "In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?" Those who answered "yes" were also asked how many times they had fallen in the previous 12 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With > 2 cm of Height Loss', 'timeFrame': '5 years', 'description': 'Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing \\>2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Fracture', 'Falls', 'Height Loss'], 'conditions': ['Atherosclerosis', 'Cardiovascular Diseases', 'Hypercholesterolemia', 'Hypertension', 'Diabetes Mellitus', 'Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '22723583', 'type': 'RESULT', 'citation': "Schwartz AV, Margolis KL, Sellmeyer DE, Vittinghoff E, Ambrosius WT, Bonds DE, Josse RG, Schnall AM, Simmons DL, Hue TF, Palermo L, Hamilton BP, Green JB, Atkinson HH, O'Connor PJ, Force RW, Bauer DC. Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial. Diabetes Care. 2012 Jul;35(7):1525-31. doi: 10.2337/dc11-2184."}, {'pmid': '26305617', 'type': 'DERIVED', 'citation': 'Schwartz AV, Chen H, Ambrosius WT, Sood A, Josse RG, Bonds DE, Schnall AM, Vittinghoff E, Bauer DC, Banerji MA, Cohen RM, Hamilton BP, Isakova T, Sellmeyer DE, Simmons DL, Shibli-Rahhal A, Williamson JD, Margolis KL. Effects of TZD Use and Discontinuation on Fracture Rates in ACCORD Bone Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4059-66. doi: 10.1210/jc.2015-1215. Epub 2015 Aug 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.', 'detailedDescription': 'Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Fulfills criteria for inclusion in the ACCORD main trial\n* Must have been randomized into the ACCORD study and be a participant from the five CCNs in the ACCORD-BONE ancillary study.\n\nExclusion criteria:\n\n* Fulfills criteria for exclusion in the ACCORD main trial'}, 'identificationModule': {'nctId': 'NCT00324350', 'acronym': 'ACCORD-BONE', 'briefTitle': 'Intensive Glycemic Control and Skeletal Health Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)', 'orgStudyIdInfo': {'id': 'R01DK069514', 'link': 'https://reporter.nih.gov/quickSearch/R01DK069514', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%)', 'interventionNames': ['Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)', 'interventionNames': ['Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents']}], 'interventions': [{'name': 'hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents', 'type': 'DRUG', 'description': 'type 2 diabetes treatments, per standard of care', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Berman Center for Outcomes & Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27106', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Veterans Affairs', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Population Health Research Institute', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Ann V. Schwartz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}