Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT02470403
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2015-06-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch', 'otherNumAtRisk': 44, 'otherNumAffected': 43, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: Placebo Once Daily', 'description': 'Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.', 'otherNumAtRisk': 44, 'otherNumAffected': 39, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner', 'otherNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;', 'otherNumAtRisk': 43, 'otherNumAffected': 43, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2: Placebo Three Times Daily', 'description': 'Matching placebo tablets tid before meals.', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual impairment', 'stats': [{'groupId': 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11}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Faeces hard', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematochezia', 'stats': 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'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paranasal sinus discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Percent Change in Body Weight From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}, {'id': 'OG001', 'title': 'Part 1: Placebo Once Daily', 'description': 'Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.'}], 'classes': [{'title': 'All subjects (n= 42, 43)', 'categories': [{'measurements': [{'value': '-5.51', 'groupId': 'OG000', 'lowerLimit': '-6.09', 'upperLimit': '-4.93'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '0.78'}]}]}, {'title': 'Dysglycemic subjects (n= 22, 23)', 'categories': [{'measurements': [{'value': '-6.55', 'groupId': 'OG000', 'lowerLimit': '-7.34', 'upperLimit': '-5.77'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '1.09'}]}]}, {'title': 'Normoglycemic subjects (n= 20,20)', 'categories': [{'measurements': [{'value': '-4.46', 'groupId': 'OG000', 'lowerLimit': '-5.31', 'upperLimit': '-3.60'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '-0.77', 'upperLimit': '0.94'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-5.70', 'ciLowerLimit': '-6.52', 'ciUpperLimit': '-4.87', 'groupDescription': 'This analysis included all subjects. The following criteria were assessed:\n\n1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-6.85', 'ciLowerLimit': '-7.96', 'ciUpperLimit': '-5.73', 'groupDescription': 'This analysis included dysglycemic subjects. The following criteria were assessed:\n\n1. upper confidence limit of 80% CI for treatment difference was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-4.55', 'ciLowerLimit': '-5.76', 'ciUpperLimit': '-3.34', 'groupDescription': 'This analysis included normoglycemic subjects. The following criteria were assessed:\n\n1. upper confidence limit of 80% CI for treatment difference was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12 (Day 85)', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100.\n\nA longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.'}, {'type': 'PRIMARY', 'title': 'Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}, {'id': 'OG001', 'title': 'Part 1: Placebo Once Daily', 'description': 'Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.'}], 'classes': [{'title': 'With at least one AE (any AE)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'This endpoint reports patients with at least one AE (any AE), serious AE and death.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects that received any study drug.'}, {'type': 'PRIMARY', 'title': 'Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}, {'id': 'OG001', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG002', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}, {'id': 'OG003', 'title': 'Part 1 and 2 : Pooled Placebo', 'description': 'Placebo subjects were pooled between the 2 parts and were considered a single treatment arm for the analyses'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.17', 'groupId': 'OG000', 'lowerLimit': '-2.21', 'upperLimit': '-0.12'}, {'value': '-1.73', 'groupId': 'OG001', 'lowerLimit': '-2.75', 'upperLimit': '-0.70'}, {'value': '-1.71', 'groupId': 'OG002', 'lowerLimit': '-2.74', 'upperLimit': '-0.69'}, {'value': '0.66', 'groupId': 'OG003', 'lowerLimit': '-0.46', 'upperLimit': '1.79'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.83', 'ciLowerLimit': '-2.16', 'ciUpperLimit': '-1.51', 'groupDescription': 'This analysis on all subjects. The following criteria were assessed:\n\n1. upper confidence limit of 80% CI for treatment difference was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.39', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '-1.84', 'groupDescription': 'This analysis on all subjects. The following criteria were assessed:\n\n1. upper confidence limit of 80% CI for treatment difference was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.38', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '-1.83', 'groupDescription': 'This analysis on all subjects. The following criteria were assessed:\n\n1. upper confidence limit of 80% CI for treatment difference was less than 0, and\n2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2 (Day 14)', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose.\n\nPercent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100. A longitudinal mixed effects model for percent change in body weight was used.\n\nThe longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate.', 'unitOfMeasure': 'Percent change', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14.'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}, {'id': 'OG002', 'title': 'Part 2: Placebo Three Times Daily', 'description': 'Matching placebo tablets tid before meals.'}], 'classes': [{'title': 'At least one AE (Any AE)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'This endpoint reports patients with at least one AE (any AE), serious AE and death', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects that received any study drug.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '-1.99', 'groupId': 'OG000', 'lowerLimit': '-2.89', 'upperLimit': '-1.09'}, {'value': '-1.73', 'groupId': 'OG001', 'lowerLimit': '-2.62', 'upperLimit': '-0.84'}]}]}, {'title': 'Normoglycemic (n=20, 20)', 'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-2.36', 'upperLimit': '-0.57'}, {'value': '-1.70', 'groupId': 'OG001', 'lowerLimit': '-2.60', 'upperLimit': '-0.80'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose.\n\nPercent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100. A longitudinal mixed effects model for percent change in body weight was used.\n\nThe longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=22)', 'categories': [{'measurements': [{'value': '1230', 'spread': '328', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemic (n=18)', 'categories': [{'measurements': [{'value': '1220', 'spread': '327', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=40)', 'categories': [{'measurements': [{'value': '1230', 'spread': '323', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=22)', 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '0.517', 'upperLimit': '4.03'}]}]}, {'title': 'Normoglycemic (n=18)', 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '0.517', 'upperLimit': '6.00'}]}]}, {'title': 'Overall (n=40)', 'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '0.517', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=22)', 'categories': [{'measurements': [{'value': '11600', 'spread': '3260', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemic (n=18)', 'categories': [{'measurements': [{'value': '12800', 'spread': '4860', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=40)', 'categories': [{'measurements': [{'value': '12100', 'spread': '4050', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=22)', 'categories': [{'measurements': [{'value': '11600', 'spread': '3260', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemic (n=18)', 'categories': [{'measurements': [{'value': '12800', 'spread': '4860', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=40)', 'categories': [{'measurements': [{'value': '12100', 'spread': '4050', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=22)', 'categories': [{'measurements': [{'value': '14.1', 'spread': '4.67', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemic (n=18)', 'categories': [{'measurements': [{'value': '13.2', 'spread': '4.42', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=40)', 'categories': [{'measurements': [{'value': '13.7', 'spread': '4.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.', 'unitOfMeasure': 'Liter/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}], 'classes': [{'title': 'Dysglycemic (n=14)', 'categories': [{'measurements': [{'value': '110', 'spread': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Normoglycemic (n=8)', 'categories': [{'measurements': [{'value': '106', 'spread': '31.2', 'groupId': 'OG000'}]}]}, {'title': 'Overall (n=22)', 'categories': [{'measurements': [{'value': '109', 'spread': '26.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 20)', 'categories': [{'measurements': [{'value': '728', 'spread': '274', 'groupId': 'OG000'}, {'value': '513', 'spread': '176', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Normoglycemic (n= 19, 19)', 'categories': [{'measurements': [{'value': '767', 'spread': '275', 'groupId': 'OG000'}, {'value': '517', 'spread': '223', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Overall (n= 38, 39)', 'categories': [{'measurements': [{'value': '747', 'spread': '272', 'groupId': 'OG000'}, {'value': '515', 'spread': '198', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '1100', 'spread': '361', 'groupId': 'OG000'}, {'value': '716', 'spread': '282', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '1030', 'spread': '266', 'groupId': 'OG000'}, {'value': '792', 'spread': '276', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Overall (n= 40, 38)', 'categories': [{'measurements': [{'value': '1070', 'spread': '315', 'groupId': 'OG000'}, {'value': '754', 'spread': '278', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 20)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '274', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.53'}, {'value': '1.00', 'spread': '176', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 1, Normoglycemic (n= 19, 19)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '275', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '0.983', 'spread': '223', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '2.00'}]}]}, {'title': 'Day 1, Overall (n= 38, 39)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '272', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '1.00', 'spread': '198', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '0.983', 'spread': '361', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '1.00', 'spread': '282', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '3.90'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '266', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '3.00'}, {'value': '0.533', 'spread': '276', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}, {'title': 'Day 14, Overall (n= 40, 38)', 'categories': [{'measurements': [{'value': '0.992', 'spread': '315', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '1.00', 'spread': '278', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 20)', 'categories': [{'measurements': [{'value': '3160', 'spread': '571', 'groupId': 'OG000'}, {'value': '3910', 'spread': '840', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Normoglycemic (n= 19, 19)', 'categories': [{'measurements': [{'value': '3280', 'spread': '674', 'groupId': 'OG000'}, {'value': '3870', 'spread': '1360', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Overall (n= 38, 39)', 'categories': [{'measurements': [{'value': '3220', 'spread': '619', 'groupId': 'OG000'}, {'value': '3890', 'spread': '1110', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '4600', 'spread': '1050', 'groupId': 'OG000'}, {'value': '4740', 'spread': '1200', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '4300', 'spread': '1160', 'groupId': 'OG000'}, {'value': '4950', 'spread': '1580', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Overall (n= 40, 38)', 'categories': [{'measurements': [{'value': '4450', 'spread': '1100', 'groupId': 'OG000'}, {'value': '4850', 'spread': '1390', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 20)', 'categories': [{'measurements': [{'value': '3170', 'spread': '573', 'groupId': 'OG000'}, {'value': '1340', 'spread': '295', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Normoglycemic (n= 18, 19)', 'categories': [{'measurements': [{'value': '3290', 'spread': '699', 'groupId': 'OG000'}, {'value': '1350', 'spread': '429', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Overall (n= 37, 39)', 'categories': [{'measurements': [{'value': '3230', 'spread': '632', 'groupId': 'OG000'}, {'value': '1350', 'spread': '362', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '4620', 'spread': '1060', 'groupId': 'OG000'}, {'value': '1940', 'spread': '600', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '4310', 'spread': '1160', 'groupId': 'OG000'}, {'value': '2000', 'spread': '586', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, Overall (n= 40, 38)', 'categories': [{'measurements': [{'value': '4470', 'spread': '1100', 'groupId': 'OG000'}, {'value': '1970', 'spread': '586', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 20)', 'categories': [{'measurements': [{'value': '24.3', 'spread': '3.97', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.53'}, {'value': '39.3', 'spread': '9.42', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 1, Normoglycemic (n= 18, 19)', 'categories': [{'measurements': [{'value': '23.8', 'spread': '5.28', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '40.5', 'spread': '12.8', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '2.00'}]}]}, {'title': 'Day 1, Overall (n= 37, 39)', 'categories': [{'measurements': [{'value': '24.1', 'spread': '4.59', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '39.9', 'spread': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '17.1', 'spread': '4.05', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '27.8', 'spread': '7.35', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '3.90'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '18.5', 'spread': '4.72', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '3.00'}, {'value': '27.2', 'spread': '8.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}, {'title': 'Day 14, Overall (n= 40, 38)', 'categories': [{'measurements': [{'value': '17.8', 'spread': '4.40', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '27.5', 'spread': '7.84', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss)', 'unitOfMeasure': 'Liter/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'OG001', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}], 'classes': [{'title': 'Day 1, Dysglycemic (n= 19, 19)', 'categories': [{'measurements': [{'value': '132', 'spread': '51.7', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.53'}, {'value': '274', 'spread': '224', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 1, Normoglycemic (n= 18, 17)', 'categories': [{'measurements': [{'value': '127', 'spread': '42.4', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '519', 'spread': '1330', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '2.00'}]}]}, {'title': 'Day 1, Overall (n= 37, 36)', 'categories': [{'measurements': [{'value': '130', 'spread': '46.8', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '6.00'}, {'value': '390', 'spread': '919', 'groupId': 'OG001', 'lowerLimit': '0.483', 'upperLimit': '3.98'}]}]}, {'title': 'Day 14, Dysglycemic (n= 20, 16)', 'categories': [{'measurements': [{'value': '108', 'spread': '52.5', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '580', 'spread': '1380', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '3.90'}]}]}, {'title': 'Day 14, Normoglycemic (n= 20, 19)', 'categories': [{'measurements': [{'value': '112', 'spread': '34.1', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '3.00'}, {'value': '267', 'spread': '493', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}, {'title': 'Day 14, Overall (n= 40, 35)', 'categories': [{'measurements': [{'value': '110', 'spread': '43.7', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '4.50'}, {'value': '410', 'spread': '997', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '3.92'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss)', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}, {'id': 'FG001', 'title': 'Part 1: Placebo Once Daily', 'description': 'Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.'}, {'id': 'FG002', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'FG003', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}, {'id': 'FG004', 'title': 'Part 2: Placebo Three Times Daily', 'description': 'Matching placebo tablets tid before meals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Dysglycemic', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Normoglycemic', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subject/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects were stratified by their glycemic status (dysglycemic or normoglycemic) and randomized to LIK066 or placebo within each stratum in each part of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '181', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: LIK066 150 mg Once Daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch'}, {'id': 'BG001', 'title': 'Part 1: Placebo Once Daily', 'description': 'Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.'}, {'id': 'BG002', 'title': 'Part 2: LIK066 75 mg Twice Daily (Bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner'}, {'id': 'BG003', 'title': 'Part 2: LIK066 50 mg Three Times Daily (Tid)', 'description': 'LIK066 50 mg tid before all 3 meals;'}, {'id': 'BG004', 'title': 'Part 2: Placebo Three Times Daily', 'description': 'Matching placebo tablets tid before meals.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1 (44, 44, NA,NA,NA,88)', 'categories': [{'measurements': [{'value': '39.0', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '11.07', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is not for Part 1', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is not for Part 1', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is not for Part 1', 'groupId': 'BG004'}, {'value': '40.2', 'spread': '11.54', 'groupId': 'BG005'}]}]}, {'title': 'Part 2 (NA, NA, 40,43,10,93)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This arm is not for Part 2', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm is not for Part 2', 'groupId': 'BG001'}, {'value': '42.9', 'spread': '8.96', 'groupId': 'BG002'}, {'value': '39.9', 'spread': '11.22', 'groupId': 'BG003'}, {'value': '43.4', 'spread': '12.39', 'groupId': 'BG004'}, {'value': '41.6', 'spread': '10.44', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set included all subjects that received any study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2015-06-10', 'resultsFirstSubmitDate': '2017-04-02', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-02', 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Percent Change in Body Weight From Baseline to Week 12', 'timeFrame': 'Baseline, Week 12 (Day 85)', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100.\n\nA longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate.'}, {'measure': 'Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death', 'timeFrame': '12 weeks', 'description': 'This endpoint reports patients with at least one AE (any AE), serious AE and death.'}, {'measure': 'Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)', 'timeFrame': 'Baseline, Week 2 (Day 14)', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose.\n\nPercent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100. A longitudinal mixed effects model for percent change in body weight was used.\n\nThe longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate.'}, {'measure': 'Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death', 'timeFrame': '2 weeks', 'description': 'This endpoint reports patients with at least one AE (any AE), serious AE and death'}], 'secondaryOutcomes': [{'measure': 'Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms', 'timeFrame': 'Baseline, Week 2', 'description': 'Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose.\n\nPercent change is calculated as \\[(post baseline- Baseline) /Baseline\\] \\* 100. A longitudinal mixed effects model for percent change in body weight was used.\n\nThe longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate.'}, {'measure': 'Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.'}, {'measure': 'Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.'}, {'measure': 'Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.'}, {'measure': 'Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.'}, {'measure': 'The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.'}, {'measure': 'The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study', 'timeFrame': 'Day 84', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.'}, {'measure': 'Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss)'}, {'measure': 'Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss)'}, {'measure': 'Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss)'}, {'measure': 'Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss)'}, {'measure': 'The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss)'}, {'measure': 'The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study', 'timeFrame': 'Day 1, Day 14', 'description': 'Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus'], 'conditions': ['Elevated Body Mass Index']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=172', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.\n* Patients with dysglycemia are patients with: Fasting plasma glucose \\>100mg/dL (5.6 mmol/L), or HbA1c \\> 5.7% and \\< 10% at screening.\n* Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.\n* If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.\n* Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening\n\nKey Exclusion Criteria:\n\n* Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders\n* Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption\n* Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder\n* Pregnant or nursing (lactating) women, and women of child-bearing potential'}, 'identificationModule': {'nctId': 'NCT02470403', 'briefTitle': 'Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group, 2-part Study Investigating the Effect of LIK066 on Body Weight in Dysglycemic (Prediabetes or Type 2 Diabetes) and Normoglycemic Patients With Elevated Body Mass Index', 'orgStudyIdInfo': {'id': 'CLIK066X2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: LIK066 150 mg once daily (qd)', 'description': 'LIK066 150 mg qd within 15 minutes before starting lunch', 'interventionNames': ['Drug: LIK066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Placebo once daily', 'description': 'Matching placebo tablets of LCZ696 150 mg within 15 minutes before starting lunch.', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LIK066 75 mg twice daily (bid)', 'description': 'LIK066 75 mg bid before breakfast and dinner', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LIK066 50 mg three times daily (tid)', 'description': 'LIK066 50 mg tid before all 3 meals;', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo three times daily', 'description': 'Matching placebo tablets tid before meals.', 'interventionNames': ['Drug: LIK066']}], 'interventions': [{'name': 'LIK066', 'type': 'DRUG', 'description': 'LIK066 25 mg tablets', 'armGroupLabels': ['Part 1: LIK066 150 mg once daily (qd)', 'Part 1: Placebo once daily', 'Part 2: Placebo three times daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets', 'armGroupLabels': ['Part 2: LIK066 50 mg three times daily (tid)', 'Part 2: LIK066 75 mg twice daily (bid)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}