Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-11 @ 5:06 AM
Study NCT ID:
NCT02004366
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Linagliptin Inpatient Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priyathama.vellanki@emory.edu', 'phone': '404-778-1665', 'title': 'Priyathama Vellanki', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '13 weeks (average 5 days in hospital and 12 weeks after discharge)', 'description': 'Adverse Events were monitored/assessed without regard to the specific Adverse Event Term', 'eventGroups': [{'id': 'EG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 25, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 15, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 3, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 1, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Reintervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ICU admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Resurgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Differences in Glycemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'spread': '47', 'groupId': 'OG000'}, {'value': '159', 'spread': '41', 'groupId': 'OG001'}, {'value': '126', 'spread': '22', 'groupId': 'OG002'}, {'value': '132', 'spread': '28', 'groupId': 'OG003'}, {'value': '142', 'spread': '24', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia <70 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Subjects with Hypoglycemia \\<70 mg/dl', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Subjects with BG \\> 300 mg/dl', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Dose of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '0.1', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '0.1', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Total daily dose of insulin', 'unitOfMeasure': 'units/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During Hospitalization', 'description': 'Length of hospital stay (ONLY for inpatient arms 1 and 2)', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Length of hospital stay is applicable ONLY for inpatient arms (1 and 2)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring ICU Care During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily+ correction doses of aspart or lispro if needed\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Transfer to ICU is applicable ONLY for inpatient arms (1 and 2)'}, {'type': 'SECONDARY', 'title': 'Hospital Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Subjects with composite complication (ONLY for inpatient arms 1 and 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Composite complication during hospitalization is applicable ONLY for inpatient arms (1 and 2)'}, {'type': 'SECONDARY', 'title': 'Acute Renal Failure During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Acute renal failure during hospitalization is applicable ONLY for inpatient arms (1 and 2)'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospital mortality is applicable ONLY for inpatients arms (1 and 2)'}, {'type': 'SECONDARY', 'title': 'Fasting BG Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'spread': '44', 'groupId': 'OG000'}, {'value': '167', 'spread': '44', 'groupId': 'OG001'}, {'value': '125', 'spread': '22', 'groupId': 'OG002'}, {'value': '133', 'spread': '27', 'groupId': 'OG003'}, {'value': '141', 'spread': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Hospitalization (average 5 days) and outpatient up to 12 weeks', 'description': 'Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects With Wound and Other Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During Hospitalization and outpatient up to 12 weeks', 'description': 'Subjects with wound and other infections.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'HbA1c Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '0.8', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '1.0', 'groupId': 'OG003'}, {'value': '8.6', 'spread': '2.7', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Admission to the hospital and 12-week follow-up outpatient visit', 'description': 'HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).', 'unitOfMeasure': '% DCCT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia < 40 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Inpatient and up to 12 weeks outpatient', 'description': 'Subjects with Hypoglycemia \\< 40 mg/dl', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergency Room Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after discharge', 'description': 'Number of ER visits ONLY for outpatient arms 3,4, and 5.', 'unitOfMeasure': 'Visits', 'reportingStatus': 'POSTED', 'populationDescription': 'Emergency visits reported only for outpatient time. Inpatient (hospital) patients cannot have ER visits'}, {'type': 'SECONDARY', 'title': 'Subjects With Surgical Reinterventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Inpatient and up to 12 weeks outpatient', 'description': 'Subjects with surgical re-interventions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Outpatient Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily+ correction doses of aspart or lispro if needed\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'OG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'OG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'OG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'OG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after discharge', 'description': 'Deaths among patients after hospital discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Deaths after hospital discharge are applicable ONLY for outpatient arms (3, 4 and 5).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily + correction doses of aspart or lispro if needed.\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'FG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'FG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'FG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'FG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}], 'periods': [{'title': 'In-hospital', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '122'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'On Discharge', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '93'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '92'}, {'groupId': 'FG003', 'numSubjects': '93'}, {'groupId': 'FG004', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited between February 2014 and October 2016. Patients who participated in the in-hospital study period were invited to enroll in the prospective outpatient study. Of 250 in-patient participants, 224 accepted enrollment into outpatient study.', 'preAssignmentDetails': "Of the 295 subjects consented, there were 15 screen failures. 30 (out of remaining 280 patients) were excluded from participation: 11 patients stayed \\<24 hours, 1 patient received corticosteroids, and 18 patients didn't receive medication. Therefore, 250 patients started the study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '474', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily+ correction doses of aspart or lispro if needed\n\nLinagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed'}, {'id': 'BG001', 'title': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed\n\nBasal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed'}, {'id': 'BG002', 'title': 'Linagliptin on Discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.\n\nLinagliptin: Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.'}, {'id': 'BG003', 'title': 'Linagliptin+50%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 50% Glargine dose on discharge: Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.'}, {'id': 'BG004', 'title': 'Linagliptin+80%Glargine Dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.\n\nLinagliptin + 80% Glargine: Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'In-hospital', 'categories': [{'measurements': [{'value': '58', 'spread': '11', 'groupId': 'BG000'}, {'value': '58', 'spread': '12', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG004'}, {'value': '57.8', 'spread': '11.3', 'groupId': 'BG005'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '10.0', 'groupId': 'BG002'}, {'value': '57.1', 'spread': '11.7', 'groupId': 'BG003'}, {'value': '50.7', 'spread': '11.5', 'groupId': 'BG004'}, {'value': '56.7', 'spread': '11.3', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'In-hospital', 'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}]}, {'title': 'Discharge', 'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Arms are not relevant to the named period', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'In-hospital Black', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '117', 'groupId': 'BG005'}]}]}, {'title': 'In-hospital White', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}]}]}, {'title': 'In-hospital Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}]}]}, {'title': 'In-hospital Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}, {'title': 'Discharge Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '111', 'groupId': 'BG005'}]}]}, {'title': 'Discharge White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}]}]}, {'title': 'Discharge Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}]}]}, {'title': 'Discharge Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'In-hospital', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '250', 'groupId': 'BG005'}]}, {'title': 'Discharged', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '224', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants are represented for the two stages of the study (in-hospital and discharge), and are counted more than once in the Total.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-19', 'size': 1584301, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-02T16:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2013-11-19', 'resultsFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-02', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Glycemic Control', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia <70 mg/dl', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Subjects with Hypoglycemia \\<70 mg/dl'}, {'measure': 'Hyperglycemia', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Subjects with BG \\> 300 mg/dl'}, {'measure': 'Daily Dose of Insulin', 'timeFrame': 'Inpatient (average 5 days) and outpatient up to 12 weeks', 'description': 'Total daily dose of insulin'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'During Hospitalization', 'description': 'Length of hospital stay (ONLY for inpatient arms 1 and 2)'}, {'measure': 'Number of Participants Requiring ICU Care During Hospitalization', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization'}, {'measure': 'Hospital Complications', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Subjects with composite complication (ONLY for inpatient arms 1 and 2)'}, {'measure': 'Acute Renal Failure During Hospitalization', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)'}, {'measure': 'Hospital Mortality', 'timeFrame': 'During Hospitalization-average 5 days', 'description': 'Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.'}, {'measure': 'Fasting BG Concentration', 'timeFrame': 'During Hospitalization (average 5 days) and outpatient up to 12 weeks', 'description': 'Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)'}, {'measure': 'Subjects With Wound and Other Infections', 'timeFrame': 'During Hospitalization and outpatient up to 12 weeks', 'description': 'Subjects with wound and other infections.'}, {'measure': 'HbA1c Level', 'timeFrame': 'Admission to the hospital and 12-week follow-up outpatient visit', 'description': 'HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).'}, {'measure': 'Hypoglycemia < 40 mg/dl', 'timeFrame': 'Inpatient and up to 12 weeks outpatient', 'description': 'Subjects with Hypoglycemia \\< 40 mg/dl'}, {'measure': 'Emergency Room Visits', 'timeFrame': '3 months after discharge', 'description': 'Number of ER visits ONLY for outpatient arms 3,4, and 5.'}, {'measure': 'Subjects With Surgical Reinterventions', 'timeFrame': 'Inpatient and up to 12 weeks outpatient', 'description': 'Subjects with surgical re-interventions.'}, {'measure': 'Outpatient Mortality', 'timeFrame': '3 months after discharge', 'description': 'Deaths among patients after hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Linagliptin', 'hospital hyperglycemia', 'inpatient diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are \\> 140 mg/dl.\n\nThe patients will be monitored for their blood sugars while the hospital.\n\nIf patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.', 'detailedDescription': 'Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily glucose concentration and frequency of hypoglycemic events, is different between treatment with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog before meals in general surgery patients with T2D.\n\nSpecific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or female surgical non-ICU patients ages between18 and 80 years\n2. A known history of T2D \\> 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.\n3. Subjects with a BG \\>140 mg and \\< 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \\< 18 mEq/L or positive serum or urinary ketones)\n\nExclusion Criteria:\n\n1. Age \\< 18 or \\> 80 years.\n2. Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).\n3. Subjects with a history of type 1 diabetes (suggested by BMI \\< 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).\n4. Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.\n5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.\n6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.\n7. Patients with clinically relevant pancreatic or gallbladder disease.\n8. Patients with previous history of pancreatitis\n9. Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR \\< 30 ml/min).\n10. Chronic use of steroid with total daily dose (prednisone equivalent) \\>5 mg/day\n11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.\n12. Pregnancy or breast feeding at time of enrollment into the study.\n13. Patients who received supplemental sliding scale insulin \\>72 hours prior to randomization\n14. Patients who received basal insulin \\> 48 hours prior to randomization'}, 'identificationModule': {'nctId': 'NCT02004366', 'briefTitle': 'Linagliptin Inpatient Trial', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'IRB00066548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linagliptin In-hospital', 'description': 'Linagliptin once daily+ correction doses of aspart or lispro if needed', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basal Bolus In-hospital', 'description': 'Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed', 'interventionNames': ['Drug: Basal Bolus']}, {'type': 'EXPERIMENTAL', 'label': 'Linagliptin on discharge', 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.', 'interventionNames': ['Drug: Linagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Linagliptin+50%Glargine dose on d/c', 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.', 'interventionNames': ['Drug: Linagliptin + 50% Glargine dose on discharge']}, {'type': 'EXPERIMENTAL', 'label': 'Linagliptin+80%Glargine dose on d/c', 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.', 'interventionNames': ['Drug: Linagliptin + 80% Glargine']}], 'interventions': [{'name': 'Linagliptin', 'type': 'DRUG', 'otherNames': ['Tradjenta'], 'description': 'Linagliptin once daily + correction doses of rapid acting insulin if needed', 'armGroupLabels': ['Linagliptin In-hospital']}, {'name': 'Basal Bolus', 'type': 'DRUG', 'otherNames': ['Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)'], 'description': 'Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed', 'armGroupLabels': ['Basal Bolus In-hospital']}, {'name': 'Linagliptin', 'type': 'DRUG', 'otherNames': ['Trajenta'], 'description': 'Patients with admission A1C \\< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.', 'armGroupLabels': ['Linagliptin on discharge']}, {'name': 'Linagliptin + 50% Glargine dose on discharge', 'type': 'DRUG', 'otherNames': ['Trajenta, Lantus'], 'description': 'Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.', 'armGroupLabels': ['Linagliptin+50%Glargine dose on d/c']}, {'name': 'Linagliptin + 80% Glargine', 'type': 'DRUG', 'otherNames': ['Trajenta, Lantus'], 'description': 'Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.', 'armGroupLabels': ['Linagliptin+80%Glargine dose on d/c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Guillermo E Umpierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University SOM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'Rush University', 'class': 'OTHER'}, {'name': 'University of Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Guillermo Umpierrez, MD', 'investigatorAffiliation': 'Emory University'}}}}