Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-04 @ 9:44 AM
Study NCT ID:
NCT01135992
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2010-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'C571886', 'term': 'insulin degludec'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)', 'description': 'Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator', 'eventGroups': [{'id': 'EG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.', 'otherNumAtRisk': 142, 'otherNumAffected': 0, 'seriousNumAtRisk': 142, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Cholelithiasis (IGlar)', 'notes': '(week 4) (N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiaisis (IDeg)', 'notes': '(week 16) (N=129)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiasis (Total)', 'notes': '(N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lumbar spinal stenosis (IGlar)', 'notes': '(week 4) (N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lumbar spinal stenosis (IDeg)', 'notes': '(week 16) (N=129)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lumbar spinal stenosis (Total)', 'notes': '(N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Carotid artery occlusion (IGlar)', 'notes': '(week 4)(N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Carotid artery occlusion (IDeg)', 'notes': '(week 16)(N=129)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Carotid artery occlusion (Total)', 'notes': '(N=142)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HbA1c (Glycosylated Haemoglobin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'Week 4 (N=128) (IGlar)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N=122)(IDeg)', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 and Week 16', 'description': 'HbA1C at week 4 and 16', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'Week 4 (N=128) (IGlar)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N=122) (IDeg)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 and Week 16', 'description': 'FPG at week 4 and 16', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'Week 4(N= 142) (IGlar)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N=129) (IDeg)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 4, Week 16', 'description': 'Change from baseline in body weight after week 4 and after week 16', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)'}, {'type': 'SECONDARY', 'title': 'Rate of Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'Adverse events (N=142)(week 4)(IGlar)', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs (N=142 ) (week 4)(IGlar)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Severe AEs (N=142)(week 4) (IGlar)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AEs (N=142) (week 4)(IGlar)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'Mild AEs (N=142)(week 4) (IGlar)', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}, {'title': 'Fatal AEs (N=142) (week 4) (IGlar)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adverse events (N=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs (n=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Severe AEs (N=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AEs (N=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}]}]}, {'title': 'Mild AEs (N=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}]}]}, {'title': 'Fatal AEs (N=129) (week 16) (IDeg)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Events (N=142) (Total)', 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs (N=142) (Total)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Severe AEs (N=142) (Total)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AEs (N=142) (Total)', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'Mild AEs (N=142) (Total)', 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}]}]}, {'title': 'Fatal AEs (N=142)(Total)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': "Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect", 'unitOfMeasure': 'events per 100 patient years', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.'}, {'type': 'SECONDARY', 'title': 'Rate of Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'IGlar (N=142) (week 4)', 'categories': [{'measurements': [{'value': '453', 'groupId': 'OG000'}]}]}, {'title': 'IDeg (N=129) (week 16)', 'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': 'Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.', 'unitOfMeasure': 'episodes per 100 patient years', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.'}, {'type': 'SECONDARY', 'title': 'Rate of Nocturnal Confirmed Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'classes': [{'title': 'IGlar (week 4) (N=142)', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'IDeg (week 16) (N=129)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': 'Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.', 'unitOfMeasure': 'episodes per 100 patient years', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'Exposed', 'achievements': [{'comment': 'One subject was withdrawn before being exposed.', 'groupId': 'FG000', 'numSubjects': '142'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The trial was conducted at 27 sites in the United States of America (U.S.)', 'preAssignmentDetails': 'The trial was conducted on subjects with type 2 diabetes mellitus currently treated with IGlar once daily (OD) and oral antidiabetic drug (OAD) therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IGlar/IDeg', 'description': 'Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \\[OAD\\] treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c (glycosylated haemoglobin) at baseline', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG) at baseline', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight at baseline', 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'spread': '20.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis set (FAS)-Includes 129 subjects only as 13 subjects did not receive IDeg.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'dispFirstSubmitDate': '2011-02-24', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2010-05-31', 'dispFirstSubmitQcDate': '2011-03-09', 'resultsFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2010-05-31', 'dispFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c (Glycosylated Haemoglobin)', 'timeFrame': 'Week 4 and Week 16', 'description': 'HbA1C at week 4 and 16'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose (FPG)', 'timeFrame': 'Week 4 and Week 16', 'description': 'FPG at week 4 and 16'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Week 0, Week 4, Week 16', 'description': 'Change from baseline in body weight after week 4 and after week 16'}, {'measure': 'Rate of Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': "Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect"}, {'measure': 'Rate of Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': 'Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.'}, {'measure': 'Rate of Nocturnal Confirmed Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)', 'description': 'Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months\n* HbA1c maximum 10 % by central laboratory analysis\n* Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination\n\nExclusion Criteria:\n\n* Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone\n* Cardiovascular disease (CVD) defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to Visit 1\n* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months\n* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements\n* Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period\n* Known or suspected hypersensitivity to trial products or related products'}, 'identificationModule': {'nctId': 'NCT01135992', 'acronym': 'BEGIN™', 'briefTitle': 'Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)', 'orgStudyIdInfo': {'id': 'NN1250-3839'}, 'secondaryIdInfos': [{'id': 'U1111-1114-8802', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IGlar/IDeg', 'interventionNames': ['Drug: insulin glargine']}, {'type': 'EXPERIMENTAL', 'label': 'IDeg 3TW', 'interventionNames': ['Drug: insulin degludec']}], 'interventions': [{'name': 'insulin degludec', 'type': 'DRUG', 'description': 'Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks', 'armGroupLabels': ['IDeg 3TW']}, {'name': 'insulin glargine', 'type': 'DRUG', 'description': 'Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec', 'armGroupLabels': ['IGlar/IDeg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Clinical Trial Call Center', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Clinical Trial Call Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 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