Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03760068
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mylan Insulin Aspart Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'keri.vaughan@mylan.com', 'phone': '+1 267.980.5015', 'title': 'Keri L. Vaughan', 'organization': 'Sr. Director Global Clinical Operations, General Medicine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 92, 'seriousNumAtRisk': 238, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.', 'otherNumAtRisk': 240, 'deathsNumAtRisk': 240, 'otherNumAffected': 99, 'seriousNumAtRisk': 240, 'deathsNumAffected': 1, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Glycosylated Hemoglobin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Crystal Urine Present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Orophayngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Colititis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Incision Site Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Perineal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Hypoglycemic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}, {'term': 'Victim of Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Emergent Antibody Response (TEAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D Product: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to week 24', 'description': 'The number of subjects who were TEAR positive.\n\nTEAR is defined as either one of the following:\n\n1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline\n2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.735', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.723', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline HbA1c at Week 24.', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.400', 'spread': '5.8162', 'groupId': 'OG000'}, {'value': '0.599', 'spread': '5.1553', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline plasma glucose at Week 24.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in Prandial Insulin Dose From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0079', 'spread': '0.14608', 'groupId': 'OG000'}, {'value': '-0.0008', 'spread': '0.09731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline daily mealtime insulin dose at Week 24.', 'unitOfMeasure': 'U/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in Basal Insulin Dose From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0053', 'spread': '0.06459', 'groupId': 'OG000'}, {'value': '0.0001', 'spread': '0.05152', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline total daily insulin dose at Week 24.', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in Total Daily Insulin Dose From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0178', 'spread': '0.15888', 'groupId': 'OG000'}, {'value': '0.0024', 'spread': '0.10649', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline total daily insulin dose at Week 24', 'unitOfMeasure': 'U/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}, {'type': 'SECONDARY', 'title': 'Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'OG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1180', 'spread': '2.09287', 'groupId': 'OG000'}, {'value': '0.0999', 'spread': '1.86471', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change in 7-point SMBG profile from baseline to Week 24', 'unitOfMeasure': 'mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 1 Diabetes Patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'FG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Subject Moved Out of State', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MYL-1601D Product (100 U/mL)', 'description': 'MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'BG001', 'title': 'FlexPen NovoLog® (100 U/mL)', 'description': 'FlexPen NovoLog® (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge.\n\nSubjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Screening Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.56', 'spread': '4.221', 'groupId': 'BG000'}, {'value': '27.00', 'spread': '4.191', 'groupId': 'BG001'}, {'value': '27.28', 'spread': '4.211', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Type 1 Diabetes Patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-14', 'size': 872314, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-10T15:54', 'hasProtocol': True}, {'date': '2020-03-02', 'size': 1584543, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-10T15:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2018-11-21', 'resultsFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-06', 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Emergent Antibody Response (TEAR)', 'timeFrame': 'Baseline to week 24', 'description': 'The number of subjects who were TEAR positive.\n\nTEAR is defined as either one of the following:\n\n1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline\n2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline HbA1c at Week 24.'}, {'measure': 'Change in Fasting Plasma Glucose From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline plasma glucose at Week 24.'}, {'measure': 'Change in Prandial Insulin Dose From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline daily mealtime insulin dose at Week 24.'}, {'measure': 'Change in Basal Insulin Dose From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline total daily insulin dose at Week 24.'}, {'measure': 'Change in Total Daily Insulin Dose From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change from baseline total daily insulin dose at Week 24'}, {'measure': 'Change in 7-point Self-monitored Blood Glucose (SMBG) Profile From Baseline', 'timeFrame': 'Baseline to week 24', 'description': 'Mean (SD) change in 7-point SMBG profile from baseline to Week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '36114990', 'type': 'DERIVED', 'citation': 'Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog(R)) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.', 'detailedDescription': 'This is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with T1DM comparing the safety and efficacy of MYL-1601D with NovoLog®.\n\nAfter up to 3-week screening period, all subjects will be titrated on NovoLog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin Lantus®. After run-in period, subjects will be randomized; one group will receive MYL-1601D, while the other group will receive NovoLog® for 24 weeks. A follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of MYL-1601D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Written and signed informed consent.\n2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.\n3. Subject is able and willing to comply with the requirements of the study protocol.\n\nExclusion Criteria\n\n1. History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.\n2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.\n3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.\n4. Any elective surgery requiring hospitalization planned during the study period.\n5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.\n6. Subjects with major depressive illness in the last 3 years.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"}, 'identificationModule': {'nctId': 'NCT03760068', 'briefTitle': 'Mylan Insulin Aspart Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D With NovoLog® in Type 1 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': 'MYL-1601D-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MYL-1601D Product (100 U/mL)', 'interventionNames': ['Drug: MYL-1601D Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FlexPen NovoLog® (100 U/mL)', 'interventionNames': ['Drug: FlexPen NovoLog®']}], 'interventions': [{'name': 'MYL-1601D Product', 'type': 'DRUG', 'description': '(100 U/mL)', 'armGroupLabels': ['MYL-1601D Product (100 U/mL)']}, {'name': 'FlexPen NovoLog®', 'type': 'DRUG', 'description': '(100 U/mL)', 'armGroupLabels': ['FlexPen NovoLog® (100 U/mL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endocrinology Associates Montgomery', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenician Centers for Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Precision Trials', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Medical Investigations Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physician Network', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Marin Endocrine Care & Research, Inc.', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes/Lipid Management and Research Center', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes And Endocrine Associates', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Center For Clinical Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Office of Richard S. Cherlin, M.D', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '92657', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'The Rose Salter Medical Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91606', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Research Associates Inc', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Reserach Partners', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research, Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western Univ of Health Science', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '94401', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Health Services Diabetes Research Institute', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'NorCal Endocrinology and Internal Medicine', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Diabetes Research Institute', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Coastal Biomedical Research, Inc.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'The Metabolic Institute Of America (Mioa Inc)', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Dr.Ronald H. Chochinov MD,Office Of', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Creekside Endocrine Associates, PC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'New West Physicians', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Paradigm Research', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Hi Tech and Global Research, LLC', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33166', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Moonshine Research Center, Inc.', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Research Institute', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Eastern Research, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for 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