Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-07 @ 6:50 AM
Study NCT ID:
NCT00220961
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Actos Now for Prevention of Diabetes (ACT NOW)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'defronzo@uthscsa.edu', 'phone': '210-567-6691', 'title': 'Ralph DeFronzo, MD', 'organization': 'University of Texas Health Science Center at San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2.4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets', 'otherNumAtRisk': 299, 'otherNumAffected': 170, 'seriousNumAtRisk': 299, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets', 'otherNumAtRisk': 303, 'otherNumAffected': 95, 'seriousNumAtRisk': 303, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Myocardio infarction, heart failure, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 144, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 72, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'One unexplained sudden death occurred in the placebo group, and three deaths occurred in the pioglitazone group (one unexplained sudden death, one death from biliary carcinoma, and one death from a carcinoid tumor).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention of Type 2 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2.4 years', 'description': 'Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose of 2.4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Fasting Plasma Glucose', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '5', 'groupId': 'OG000'}, {'value': '25', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Insulin secretion', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.', 'unitOfMeasure': 'matsuda index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Atherosclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'OG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'carotid intima thickness', 'unitOfMeasure': 'percentage of intima', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day'}, {'id': 'FG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets - 45mg/day tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '90'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet\n\nPlacebo: Placebo tablets similar to pioglitazone tablets'}, {'id': 'BG001', 'title': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet\n\nPioglitazone: Pioglitazone tablets'}, {'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': '269', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '540', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2005-09-14', 'resultsFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-29', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of Type 2 Diabetes', 'timeFrame': '2.4 years', 'description': 'Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose of 2.4 Years', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Fasting Plasma Glucose'}, {'measure': 'Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Insulin secretion'}, {'measure': 'Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.'}, {'measure': 'Change in Atherosclerosis', 'timeFrame': 'Baseline versus 2.4 years', 'description': 'carotid intima thickness'}]}, 'conditionsModule': {'keywords': ['Impaired Glucose Tolerance', 'Type 2 Diabetes', 'Prevention', 'Pioglitazone'], 'conditions': ['Impaired Glucose Tolerance', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '33210751', 'type': 'DERIVED', 'citation': 'Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.'}, {'pmid': '26982008', 'type': 'DERIVED', 'citation': 'Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, DeFronzo RA. Diabetes Incidence and Glucose Tolerance after Termination of Pioglitazone Therapy: Results from ACT NOW. J Clin Endocrinol Metab. 2016 May;101(5):2056-62. doi: 10.1210/jc.2015-4202. Epub 2016 Mar 16.'}, {'pmid': '25603459', 'type': 'DERIVED', 'citation': 'Tripathy D, Cobb JE, Gall W, Adam KP, George T, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Reaven PD, Musi N, Ferrannini E, DeFronzo RA. A novel insulin resistance index to monitor changes in insulin sensitivity and glucose tolerance: the ACT NOW study. J Clin Endocrinol Metab. 2015 May;100(5):1855-62. doi: 10.1210/jc.2014-3824. Epub 2015 Jan 20.'}, {'pmid': '24705615', 'type': 'DERIVED', 'citation': 'Tripathy D, Clement SC, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Gastaldelli A, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, DeFronzo RA. Baseline adiponectin levels do not influence the response to pioglitazone in ACT NOW. Diabetes Care. 2014 Jun;37(6):1706-11. doi: 10.2337/dc13-1745. Epub 2014 Apr 4.'}, {'pmid': '23175674', 'type': 'DERIVED', 'citation': 'Saremi A, Schwenke DC, Buchanan TA, Hodis HN, Mack WJ, Banerji M, Bray GA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Tripathy D, DeFronzo RA, Reaven PD. Pioglitazone slows progression of atherosclerosis in prediabetes independent of changes in cardiovascular risk factors. Arterioscler Thromb Vasc Biol. 2013 Feb;33(2):393-9. doi: 10.1161/ATVBAHA.112.300346. Epub 2012 Nov 21.'}, {'pmid': '21428766', 'type': 'DERIVED', 'citation': 'DeFronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Hodis HN, Kitabchi AE, Mack WJ, Mudaliar S, Ratner RE, Williams K, Stentz FB, Musi N, Reaven PD; ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011 Mar 24;364(12):1104-15. doi: 10.1056/NEJMoa1010949.'}, {'pmid': '19640291', 'type': 'DERIVED', 'citation': 'Defronzo RA, Banerji M, Bray GA, Buchanan TA, Clement S, Henry RR, Kitabchi AE, Mudaliar S, Musi N, Ratner R, Reaven PD, Schwenke D, Stentz FB, Tripathy D. Actos Now for the prevention of diabetes (ACT NOW) study. BMC Endocr Disord. 2009 Jul 29;9:17. doi: 10.1186/1472-6823-9-17.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetes.org/', 'label': 'American Diabetes Association'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus', 'detailedDescription': 'IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (FSIVGTT) and carotid intimal media thickness using carotid ultrasound. Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose (FPG) concentration and interim medical history. Recruitment will take place over 15 months. From the time that the recruitment period ends, subjects will be followed for a total of 24 months on pioglitazone or placebo. The OGTT will be repeated at 15,27, and 39 months, or if the FPG is ≥ 126 mg/dl on the 3-month follow up visits. If the diagnosis of diabetes is established before month 39 or at month 39, the FSIVGTT and carotid ultrasound will be repeated. At 39 months, subjects will be washed out of pioglitazone or placebo and the OGTT, FSIVGTT, and carotid ultrasound will be repeated at month 45.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women\n* All ethnic groups\n* 18 years of age and older\n* Impaired glucose tolerance by glucose tolerance test (fasting glucose 95-125 mg/dl and 2 hr glucose of 140-199 mg/dl)\n* At least one of the following:\n\n * One or more components of the insulin resistance syndrome (HDL \\< 40 mg/dl in females and \\<35 mg/dl in males, fasting triglycerides \\> 150 mg/dl, blood pressure \\> 135/85 mmHg, BMI \\> 24 kg/m2, waist circumference \\> 102 cm in men and \\> 88 cm in women)\n * One or more first degree relatives with type 2 diabetes\n * History of gestational diabetes\n * Polycystic ovarian disease\n * Minority ethnic background (Mexican American, African American, Asian and Pacific Islanders, Native American)\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* Previously treated with thiazolidinediones (ever) or metformin (within one year)\n* Previously treated with a sulfonylurea, a meglitinide, an alpha glucosidase inhibitor for more than a week within last year or within the 3 months prior to randomization\n* Previously treated with insulin (other than during pregnancy) for more than one week within the last year or within the 3 months prior to randomization\n* Cardiovascular disease\n* Hospitalization for treatment of heart disease or stroke in past 6 months\n* New York Heart Association Functional Class \\> 2\n* Left bundle branch block or third degree AV block\n* Aortic stenosis\n* SBP \\> 180 mmHg or DBP \\> 105 mmHg\n* Renal disease\n* Anemia\n* Hepatitis\n* GI diseases (pancreatitis, inflammatory bowel disease)\n* Recent or significant abdominal surgery\n* Advanced pulmonary disease\n* Chronic infections\n* Weight loss \\> 10% in past 6 months\n* Pregnancy and childbearing\n* Major psychiatric disorders\n* Excessive alcohol intake\n* Thiazide use \\> 25 mg per day\n* Non-selective beta blockers\n* Niacin\n* Systemic glucocorticoids\n* Weight loss or weight gain medication\n* Thyroid disease-suboptimally treated\n* Active endocrine diseases (Cushing's, acromegaly)\n* Plasma triglycerides over 400 mg/dl (despite treatment)\n* History bladder cancer\n* Hematuria"}, 'identificationModule': {'nctId': 'NCT00220961', 'briefTitle': 'Actos Now for Prevention of Diabetes (ACT NOW)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Actos Now for Prevention of Diabetes (ACT NOW)', 'orgStudyIdInfo': {'id': '02-062A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet similar to pioglitazone tablet', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'Pioglitazone tablet similar to placebo tablet', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': 'Pioglitazone tablets - 45 mg/day', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets similar to pioglitazone tablets - 1 tablet/day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carl T. Hayden VA Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC-Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego-San Diego VA Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Health Science Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Ralph A. DeFronzo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Diabetes Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}, {'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Chief of Diabetes', 'investigatorFullName': 'Ralph DeFronzo, MD', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}