Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 4:37 PM
Study NCT ID:
NCT01128192
Status:
COMPLETED
Last Update Posted:
2014-12-25
First Post:
2009-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C517782', 'term': 'pasireotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rrhenry@ucsd.edu', 'phone': '858-552-8585', 'title': 'Principal Investigator', 'organization': 'Veterans Medical Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse events (AE) were collected in real time as reported by each study subject. The study Investigators' reviewed and evaluated each individually reported Adverse Event within one week of reporting (if not immediately upon report).", 'description': "The investigator provided a listing of each subject's AEs. The individual AEs that occurred in each subject were then identified using the Investigator's term and AE frequency was summarized by dose group and adverse event.", 'eventGroups': [{'id': 'EG000', 'title': 'Pasireotide 600 μg sc Bid', 'description': 'Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.', 'otherNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pasireotide 900 μg sc Bid', 'description': 'Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.', 'otherNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pasireotide 1200 μg sc Bid', 'description': 'Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': '10 subjects (53.6%) in the 600 µg sc bid arm. 10 subjects (53.6%) in the 900 µg sc bid arm. 5 subjects (71.4%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Cramping', 'notes': '6 subjects (31.6%) in the 600 µg sc bid arm. 9 subjects (47.4%) in the 900 µg sc bid arm. 4 subjects (57.1%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose Stools (soft stools)', 'notes': '5 subjects (26.3%) in the 600 µg sc bid arm. 13 subjects (68.4%) in the 900 µg sc bid arm. 2 subjects (28.6%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning Sensation', 'notes': '4 subjects (21.1%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': '3 subjects (15.8%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.\n\n1 subjects (14.3%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': '3 subjects (15.8%) in the 600 µg sc bid arm.\n\n1 subject (14.3%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting/emesis', 'notes': '2 subjects (10.5%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. 3 subjects (42.8%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gas (Flatulence)', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site redness', 'notes': '2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site stinging', 'notes': '2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection (common cold)', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent Stools', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Impacted wisdom tooth', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Light colored stool', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pressure in gut', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach ache', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach cramps', 'notes': '1 subject (5.3%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach fullness', 'notes': '1 subject (5.3%) in the 600 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'notes': '1 subject (5.3%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site bruise', 'notes': '1 subject (5.3%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness', 'notes': '1 subject (5.3%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': '1 subject (14.3%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Histamine-like reaction', 'notes': '1 subject (14.3%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating', 'notes': '1 subject (14.3%) in the 1200 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal reaction while voiding', 'notes': '2 subjects (10.5%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infiltration, left ACFf', 'notes': 'Procedural complication:\n\n1 subject (5.3%) in the 900 µg sc bid arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.240', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Change in fasting plasma glucose level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.339', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in fasting plasma glucose level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '-30 minutes on Day 1 and -30 minutes on Day 8', 'description': 'An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at\n\n-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}], 'classes': [{'title': 'AUC 0-30 min', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'AUC 30-180 min', 'categories': [{'measurements': [{'value': '14.72', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '12.35', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'AUC 0-180 min', 'categories': [{'measurements': [{'value': '14.29', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '11.49', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P Value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P Value', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)', 'description': 'Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change Fasting Plasma Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.62', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '-11.69', 'spread': '10.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in fasting plasma insulin level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in fasting plasma insulin level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '-30 minutes on Day 1 and -30 minutes on Day 8', 'description': 'An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.'}], 'classes': [{'title': 'AUC 0-30 min', 'categories': [{'measurements': [{'value': '-104.18', 'spread': '90.60', 'groupId': 'OG000'}, {'value': '-100.90', 'spread': '68.99', 'groupId': 'OG001'}]}]}, {'title': 'AUC 30-180 min', 'categories': [{'measurements': [{'value': '-184.96', 'spread': '126.57', 'groupId': 'OG000'}, {'value': '-262.15', 'spread': '158.58', 'groupId': 'OG001'}]}]}, {'title': 'AUC 0-180 min', 'categories': [{'measurements': [{'value': '-289.14', 'spread': '162.54', 'groupId': 'OG000'}, {'value': '-363.06', 'spread': '191.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)', 'description': 'Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Insulin Basal Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.37', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '-29.60', 'spread': '16.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Baseline Insulin Level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Change in Baseline Insulin Level', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '-30 min and -15 min on Day 2 and Day 9', 'description': 'Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.'}], 'classes': [{'title': 'AUC 0-10 min', 'categories': [{'measurements': [{'value': '-28.07', 'spread': '19.15', 'groupId': 'OG000'}, {'value': '-27.95', 'spread': '18.56', 'groupId': 'OG001'}]}]}, {'title': 'AUC 10-180 min', 'categories': [{'measurements': [{'value': '-1450.59', 'spread': '1237.44', 'groupId': 'OG000'}, {'value': '-1474.65', 'spread': '1009.00', 'groupId': 'OG001'}]}]}, {'title': 'AUC 0-180 min', 'categories': [{'measurements': [{'value': '-1478.65', 'spread': '1254.66', 'groupId': 'OG000'}, {'value': '-1502.60', 'spread': '1022.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)', 'description': 'Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Basal Endogenous Glucose Production (EGP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.112', 'spread': '0.308', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.608', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Basal EGP', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.132', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Basal EGP', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.54', 'spread': '23.47', 'groupId': 'OG000'}, {'value': '-6.28', 'spread': '16.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.178', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Low-Dose % EGP Inhibition', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.111', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Low-Dose % EGP Inhibition', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)', 'unitOfMeasure': 'percentage of EGP Inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in High Dose % Endogenous Glucose Production (EGP) Inhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.06', 'spread': '15.65', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in high-dose % EGP Inhibition', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)', 'unitOfMeasure': 'percentage of EGP inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Low-Dose Glucose Disposal Rate (GDR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.029', 'spread': '2.230', 'groupId': 'OG000'}, {'value': '0.791', 'spread': '2.144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.956', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Low-Dose Glucose Disposal Rate (GDR)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.125', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in Low-Dose Glucose Disposal Rate (GDR)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in High-Dose Glucose Disposal Rate (GDR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pasireotide 600 µg sc Bid', 'description': 'Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}, {'id': 'OG001', 'title': 'Pasireotide 900 µg sc Bid', 'description': 'Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.004', 'spread': '2.051', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '2.099', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.993', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in High-Dose Glucose Disposal Rate (GDR)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.956', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Two sided P value.', 'groupDescription': 'Change in High-Dose Glucose Disposal Rate (GDR)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pasireotide 600 μg sc Bid', 'description': '19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.'}, {'id': 'FG001', 'title': 'Pasireotide 900 μg sc Bid', 'description': '19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.'}, {'id': 'FG002', 'title': 'Pasireotide 1200 μg sc Bid', 'description': '7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were healthy men aged 18-50 years with a body mass index (BMI) ≤25 kg/m2 who came to the VA San Diego Healthcare System Metabolic Research medical clinic. Recruitment occurred between August of 2009 until March 2010.', 'preAssignmentDetails': 'Participants were excluded if they had a family history of diabetes or a baseline diagnosis of impaired glucose tolerance.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pasireotide 600 μg sc Bid', 'description': 'Pasireotide 600 μg sc bid n=19'}, {'id': 'BG001', 'title': 'Pasireotide 900 μg sc Bid', 'description': 'Pasireotide 900 μg sc bid n=19'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '24.6', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '24.45', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Nondiabetic males, aged 18-50 years with body mass index (BMI) ≤ 25. Subjects were not to have any family history of diabetes and no diagnosis of impaired glucose tolerance or gallstone disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '23.30', 'spread': '1.61', 'groupId': 'BG000'}, {'value': '23.68', 'spread': '2.04', 'groupId': 'BG001'}, {'value': '23.49', 'spread': '1.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '75.67', 'spread': '8.11', 'groupId': 'BG000'}, {'value': '74.49', 'spread': '8.41', 'groupId': 'BG001'}, {'value': '75.08', 'spread': '8.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Nondiabetic males, aged 18-50 years with body mass index (BMI) ≤ 25. Subjects were not to have any family history of diabetes and no diagnosis of impaired glucose tolerance or gallstone disease.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2009-09-15', 'resultsFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-23', 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Basal Level', 'timeFrame': '-30 min and -15 min on Day 2 and Day 9', 'description': 'Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)'}, {'measure': 'Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp', 'timeFrame': '0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)', 'description': 'Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.'}, {'measure': 'Change in Basal Endogenous Glucose Production (EGP)', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)'}, {'measure': 'Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)'}, {'measure': 'Change in High Dose % Endogenous Glucose Production (EGP) Inhibition', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)'}, {'measure': 'Change in Low-Dose Glucose Disposal Rate (GDR)', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.'}, {'measure': 'Change in High-Dose Glucose Disposal Rate (GDR)', 'timeFrame': 'Day 3 and Day 10', 'description': 'Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose Level', 'timeFrame': '-30 minutes on Day 1 and -30 minutes on Day 8', 'description': 'An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at\n\n-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed.'}, {'measure': 'Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)', 'timeFrame': '0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)', 'description': 'Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.'}, {'measure': 'Change Fasting Plasma Insulin Level', 'timeFrame': '-30 minutes on Day 1 and -30 minutes on Day 8', 'description': 'An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.'}, {'measure': 'Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)', 'timeFrame': '0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)', 'description': 'Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '23733372', 'type': 'RESULT', 'citation': 'Henry RR, Ciaraldi TP, Armstrong D, Burke P, Ligueros-Saylan M, Mudaliar S. Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. J Clin Endocrinol Metab. 2013 Aug;98(8):3446-53. doi: 10.1210/jc.2013-1771. Epub 2013 Jun 3.'}], 'seeAlsoLinks': [{'url': 'http://www.vacmr.org', 'label': 'Study site Web site'}]}, 'descriptionModule': {'briefSummary': 'This clinical study will attempt to find out why in early studies in healthy volunteers, injections under the skin of pasireotide were associated with temporary increases in both fasting and post-meal glucose levels, along with possible increases in insulin and glucagon levels. Glucose refers to the amount of sugar in your blood and insulin and glucagon levels are amounts of hormones that lower and raise blood sugar.\n\nThe purpose of the study is to evaluate the effects of pasireotide on insulin resistance and secretion. Insulin is a natural hormone made by the pancreas (a gland inside the abdomen) that controls the level of sugar in the blood. Insulin permits cells to use sugar for energy. Insulin resistance is the condition in which higher than normal amounts of insulin are necessary to allow the sugar to enter the cells. Insulin secretion refers to the amount of insulin produced by the body and released in the blood. Glucagon is a hormone (chemical substance produced by the pancreas gland in the body) which increases blood glucose.', 'detailedDescription': "This was a Phase 2, double-blinded, single-center study to assess the effects of pasireotide on insulin secretion and glucose metabolism in healthy male volunteers. Subjects who had given written informed consent and had been shown to satisfy the inclusion and exclusion criteria underwent baseline tests. An oral glucose tolerance test (OGTT) was administered on Day 1. If the OGTT results confirmed normal glycemia, the subject continued with baseline testing on Day 2 (2-step hyperglycemic clamp test with arginine stimulation) and Day 3 (2-step hyperinsulinemic euglycemic clamp (HEC) test with \\[3-3H\\]glucose). Each subject was then randomized into 1 of 3 dose groups: 600 µg twice daily (bid) delivered subcutaneously , pasireotide 900 µg bid delivered subcutaneously, or pasireotide 1200 µg bid delivered subcutaneously. Subcutaneous injections of pasireotide were given twice daily from Days 3-10 (for 8 consecutive days, starting from the evening of Day 3 and up to the morning injection on Day 10). On Study Days 8-10, the last 3 days of treatment with the pasireotide injections, the tests performed at Baseline (ie, the OGTT; the 2-step hyperglycemic clamp test with arginine stimulation; and the 2-step HEC test with \\[3-3H\\] glucose) were repeated. Subjects returned for a post-study safety follow-up visit 5 to 7 days after the last injection of the study drug and an H\\&P and safety labs (including a fasting glucose level) was performed. In addition, depending on subject convenience, a 3rd OGTT was either performed on this visit or was performed on another occasion convenient for subjects, in order to confirm that subjects' OGTT status had returned to baseline levels.\n\nThis additional post-study OGTT was added in a protocol amendment. Those subjects who completed the clinical trial and the follow-up visit before the amendment was approved were contacted and asked to return for another follow-up visit. The optional post-study OGTT was voluntary and subjects could choose not to participate. In order to reduce the severity of gastrointestinal adverse events (AEs), the protocol was amended (while keeping the blind intact) on 08 December 2009 to discontinue the pasireotide 1200 µg bid arm. The randomization scheme was subsequently adjusted to assign subjects in a 1:1 ratio to the 2 remaining arms: pasireotide 600 µg bid and pasireotide 900 µg bid."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lean, healthy, non-diabetic male.\n\nExclusion Criteria:\n\n* Family history of diabetes, BMI over 25.'}, 'identificationModule': {'nctId': 'NCT01128192', 'acronym': 'Pasireotide', 'briefTitle': 'Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Veterans Medical Research Foundation'}, 'officialTitle': 'Phase 2, Double-Blind, Randomized, Single Center Trial to Assess the Mechanism(s) Responsible for the Effect of the Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers. Version #2 05/09/2009', 'orgStudyIdInfo': {'id': 'SOM230Novartis/VMRF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pasireotide 600 µg sc bid', 'description': 'n=19. Pasireotide 600 µg sc bid', 'interventionNames': ['Drug: pasireotide']}, {'type': 'EXPERIMENTAL', 'label': 'Pasireotide 900 µg sc bid', 'description': 'n=19. Pasireotide 900 µg sc bid', 'interventionNames': ['Drug: pasireotide']}, {'type': 'EXPERIMENTAL', 'label': 'Pasireotide 1200 µg sc bid', 'description': 'n=7. Due to increased severity of gastro-intestinal side effects, this arm was discontinued. These participants were only included in the safety analysis.', 'interventionNames': ['Drug: pasireotide']}], 'interventions': [{'name': 'pasireotide', 'type': 'DRUG', 'otherNames': ['SOM230'], 'description': 'Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection.', 'armGroupLabels': ['Pasireotide 1200 µg sc bid', 'Pasireotide 600 µg sc bid', 'Pasireotide 900 µg sc bid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'CMR Center for Metabolic Research VASDHS', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Robert R Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Medical Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert R. Henry, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Veterans Medical Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Robert R. Henry, MD', 'investigatorAffiliation': 'Veterans Medical Research Foundation'}}}}