Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-03 @ 1:41 AM
Study NCT ID:
NCT02700334
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2016-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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': 'C529054', 'term': 'dapagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uiec@prodigy.net.mx', 'phone': '+52 3310585200', 'title': 'DR. MANUEL GONZALEZ ORTIZ', 'phoneExt': '34212', 'organization': 'INSTITUTO DE TERAPUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study (12 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema in upper extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Fasting Glucose levels at week 12', 'description': 'The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Postprandial Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Postprandial Glucose levels at Week 12', 'description': 'Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'First Phase of Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1096', 'spread': '388', 'groupId': 'OG000'}, {'value': '1379', 'spread': '566', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'First Phase of Insulin Secretion at Week 12', 'description': "The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.959', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Total Insulin Secretion at Week 12', 'description': 'Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at week 12.\n\nThe insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.63', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Insulin Sensitivity at Week 12', 'description': "Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at week 12.\n\nMatsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity", 'unitOfMeasure': 'index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glycosylated Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.331', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Glycosylated Hemoglobin at Week 12', 'description': 'Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Body Weight at Week 12', 'description': 'The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Body Mass Index at Week 12', 'description': 'Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Total Cholesterol levels at Week 12', 'description': 'Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Triglycerides levels at Week 12', 'description': 'Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High Density Lipoprotein Cholesterol (HDL-c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.721', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'HDL-c levels at Week 12', 'description': 'HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'ALT levels at Week 12', 'description': 'ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '27.7', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'AST levels at Week 12', 'description': 'AST levels will be evaluated with enzymatic/colorimetric techniques at week 12', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '35.4', 'groupId': 'OG000'}, {'value': '61.9', 'spread': '17.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Creatinine levels at Week 12', 'description': 'Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '261.7', 'spread': '59.5', 'groupId': 'OG000'}, {'value': '303.4', 'spread': '83.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Uric Acid levels at Week 12', 'description': 'Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'spread': '12', 'groupId': 'OG000'}, {'value': '123', 'spread': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.919', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Systolic Blood Pressure at Week 12', 'description': 'Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '10', 'groupId': 'OG000'}, {'value': '74', 'spread': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.720', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Diastolic Blood Pressure at Week 12', 'description': 'Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.\n\nDapagliflozin: 10 mg, one per day before breakfast during 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.\n\nPlacebo: one per day before breakfast during 12 weeks.'}, {'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': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '46.7', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '8.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Postprandial Glucose', 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '9.5', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '9.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'First Phase of Insulin Secretion', 'classes': [{'categories': [{'measurements': [{'value': '1126', 'spread': '604', 'groupId': 'BG000'}, {'value': '1708', 'spread': '709', 'groupId': 'BG001'}, {'value': '1417', 'spread': '656.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Insulin Secretion', 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.31', 'groupId': 'BG000'}, {'value': '0.49', 'spread': '0.17', 'groupId': 'BG001'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin Sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'spread': '1.09', 'groupId': 'BG000'}, {'value': '1.94', 'spread': '0.72', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity", 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '16.3', 'groupId': 'BG000'}, {'value': '83.5', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '82.2', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Density Lipoprotein cholesterol (HDL-c)', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '26.8', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '21.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate Aminotransferase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '34.4', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.01', 'groupId': 'BG000'}, {'value': '0.07', 'spread': '0.02', 'groupId': 'BG001'}, {'value': '0.07', 'spread': '0.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Uric Acid', 'classes': [{'categories': [{'measurements': [{'value': '334', 'spread': '70', 'groupId': 'BG000'}, {'value': '312', 'spread': '101', 'groupId': 'BG001'}, {'value': '323', 'spread': '85.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '124', 'spread': '9', 'groupId': 'BG000'}, {'value': '126', 'spread': '11', 'groupId': 'BG001'}, {'value': '125', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '10', 'groupId': 'BG000'}, {'value': '77', 'spread': '11', 'groupId': 'BG001'}, {'value': '78', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-11', 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Glucose', 'timeFrame': 'Fasting Glucose levels at week 12', 'description': 'The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12'}, {'measure': 'Postprandial Glucose', 'timeFrame': 'Postprandial Glucose levels at Week 12', 'description': 'Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12'}, {'measure': 'First Phase of Insulin Secretion', 'timeFrame': 'First Phase of Insulin Secretion at Week 12', 'description': "The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.\n\nFirst phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion"}, {'measure': 'Total Insulin Secretion', 'timeFrame': 'Total Insulin Secretion at Week 12', 'description': 'Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at week 12.\n\nThe insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.\n\nTotal insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion'}, {'measure': 'Insulin Sensitivity', 'timeFrame': 'Insulin Sensitivity at Week 12', 'description': "Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at week 12.\n\nMatsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \\[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\\]. The entered values reflect the insulin sensitivity"}, {'measure': 'Glycosylated Hemoglobin', 'timeFrame': 'Glycosylated Hemoglobin at Week 12', 'description': 'Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12'}], 'secondaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': 'Body Weight at Week 12', 'description': 'The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12'}, {'measure': 'Body Mass Index', 'timeFrame': 'Body Mass Index at Week 12', 'description': 'Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Total Cholesterol levels at Week 12', 'description': 'Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12'}, {'measure': 'Triglycerides', 'timeFrame': 'Triglycerides levels at Week 12', 'description': 'Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12'}, {'measure': 'High Density Lipoprotein Cholesterol (HDL-c)', 'timeFrame': 'HDL-c levels at Week 12', 'description': 'HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'ALT levels at Week 12', 'description': 'ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': 'AST levels at Week 12', 'description': 'AST levels will be evaluated with enzymatic/colorimetric techniques at week 12'}, {'measure': 'Creatinine', 'timeFrame': 'Creatinine levels at Week 12', 'description': 'Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12'}, {'measure': 'Uric Acid', 'timeFrame': 'Uric Acid levels at Week 12', 'description': 'Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Systolic Blood Pressure at Week 12', 'description': 'Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Diastolic Blood Pressure at Week 12', 'description': 'Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prediabetes', 'Impaired fasting glucose', 'Hyperglycemia', 'Impaired glucose tolerance', 'Glucose intolerance', 'Dapagliflozin', 'Sodium glucose cotransporter 2 inhibitor', 'SGLT2'], 'conditions': ['Prediabetes', 'Impaired Fasting Glucose', 'Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM).\n\nDapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM.\n\nThe aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes.\n\nThe investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.', 'detailedDescription': "A randomized, double-blind, placebo-controlled clinical trial in 24 patients with a diagnosis of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.\n\nThey will be assigned randomly two groups of 12 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.\n\nThere will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).\n\nThis protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.\n\nStatistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.\n\nThis protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients both sexes\n* Age between 30 and 60 years\n* Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Women with confirmed or suspected pregnancy\n* Women under lactation and/or puerperium\n* Hypersensibility to ingredients of intervention\n* Physical impossibility for taking pills\n* Known uncontrolled renal, hepatic, heart or thyroid diseased\n* Diabetes diagnosis\n* Previous treatment for glucose\n* Body Mass Index ≥35 kg/m2\n* Triglycerides ≥500 mg/dL\n* Total cholesterol ≥240 mg/dL\n* Low density lipoprotein (c-LDL) ≥190 mg/dL\n* Blood Pressure ≥140/90 mmHg'}, 'identificationModule': {'nctId': 'NCT02700334', 'briefTitle': 'Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Guadalajara'}, 'officialTitle': 'Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes', 'orgStudyIdInfo': {'id': 'DAPA-PREDIABETES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules, one per day before breakfast during 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Forxiga'], 'description': '10 mg, one per day before breakfast during 12 weeks.', 'armGroupLabels': ['Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Calcined magnesium'], 'description': 'one per day before breakfast during 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'MANUEL GONZALEZ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher Professor', 'investigatorFullName': 'Manuel González Ortiz', 'investigatorAffiliation': 'University of Guadalajara'}}}}