Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 5:05 AM
Study NCT ID:
NCT05706506
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2023-01-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)
Sponsor:
Organization:
Raw JSON
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derived Values were \\>180 mg/dl (10 mmol/L) was assessed.', 'unitOfMeasure': 'Minutes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg tirzepatide SC administered QW for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-106.09', 'spread': '22.21', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \\>180 mg/dl (10 mmol/L) was assessed.', 'unitOfMeasure': 'Minutes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Serum Glucose (FSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg tirzepatide SC administered QW for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.83', 'spread': '2.85', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in FSG was assessed.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 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{'groups': [{'id': 'FG000', 'title': '5 Milligrams (mg) Tirzepatide', 'description': 'Participants received 5 mg tirzepatide subcutaneously (SC) administered once weekly (QW) for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'Received At Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Inadvertent Enrolment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Early Discontinuation Due to Hyperglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant Moved Out of State', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '5 mg Tirzepatide', 'description': 'Participants received 5 mg tirzepatide SC administered QW for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.40', 'spread': '0.660', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. 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HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))', 'timeFrame': 'Baseline, Week 4', 'description': 'Change from Baseline in Percentage of Time per Day that CGM-derived Values were \\>180 mg/dl (10 mmol/L) was assessed.'}, {'measure': 'Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in Percentage of Time per Day that CGM-derived Values were \\>180 mg/dl (10 mmol/L) was assessed.'}, {'measure': 'Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)', 'timeFrame': 'Baseline, Week 4', 'description': 'Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \\>180 mg/dl (10 mmol/L) was assessed.'}, {'measure': 'Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \\>180 mg/dl (10 mmol/L) was assessed.'}, {'measure': 'Change From Baseline in Fasting Serum Glucose (FSG)', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in FSG was assessed.'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': 'Baseline, Week 12', 'description': 'Change from Baseline in Weight was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/385077', 'label': 'A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have Type 2 diabetes (T2D)\n* Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)\n* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening\n* Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months\n* No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes (T1D)\n* Have a clinical history of\n\n * proliferative diabetic retinopathy\n * diabetic maculopathy, or\n * non-proliferative diabetic retinopathy that requires acute treatment\n* Are at high risk for cardiovascular disease or have a history of\n\n * myocardial infarction\n * percutaneous coronary revascularization procedure\n * carotid stenting or surgical revascularization\n * nontraumatic amputation\n * peripheral vascular procedure\n * cerebrovascular accident\n * or hospitalization for congestive heart failure\n* Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure\n* Have a history of ketoacidosis or hyperosmolar state or coma\n* Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.'}, 'identificationModule': 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