Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-05 @ 12:44 AM
Study NCT ID:
NCT05514535
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycated Haemoglobin (HbA1c)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Non-inferiority of semaglutide s.c. as add-on to dose-reduced insulin glargine to that of titrated insulin glargine will be assessed based on the clinically acceptable margin of 0.3 percentage (%) for the mean treatment difference in HbA1c. Measured as percentage.'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Measured as kilogram'}, {'measure': 'Relative Change in Daily Insulin Dose', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Measured as percentage'}, {'measure': 'Change in HbA1c', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage.'}, {'measure': 'Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)', 'timeFrame': 'At end of treatment (week 40)', 'description': 'The questionnaire has been designed to measure the change in the level of satisfaction with diabetes treatment regimens in participants with diabetes who have had a recent intervention. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. Measured as score on a scale.'}, {'measure': 'Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)', 'timeFrame': 'At end of treatment (week 40)', 'description': 'Measured as count of participants'}, {'measure': 'Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)', 'timeFrame': 'At end of treatment (week 40)', 'description': 'Measured as count of participants'}, {'measure': 'Participants Achieving: HbA1c less than 7 Percentage (Yes/No)', 'timeFrame': 'At end of treatment (week 40)', 'description': 'Measured as count of participants'}, {'measure': 'Number of Severe Hypoglycaemic Episodes (Level 3)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Measured as number of episodes'}, {'measure': 'Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Measured as number of episodes'}, {'measure': 'Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'Measured as number of episodes'}, {'measure': 'Participants Achieving All of The Following Targets: HbA1c Reduced From Baseline by At Least 0.3 %; Insulin Dose Reduced From Baseline; No Hypoglycaemic Episodes; No Weight Gain', 'timeFrame': 'At end of treatment (week 40)', 'description': 'No hypoglycaemic episodes defined as less than 3.9 mmol/L \\[70 milligrams per decilitre (mg/dL)\\] confirmed by Blood Glucose meter. Outcome measure measured as count of participants.'}, {'measure': 'Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': "The questionnaire has been designed to measure satisfaction with diabetes treatment regimens in participants with diabetes. The questionnaire contains 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Measured as score on a scale."}, {'measure': 'Change in Score of Short Form 36 Version 2 (SF-36 v2)', 'timeFrame': 'From baseline (week 0) to end of treatment (week 40)', 'description': 'The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes Mellitus (T2D) mellitus greater than or equal to (\\>=) 180 days before screening.\n* Glycated haemoglobin (HbA1c) of 7-10 percentage \\[(53-86 millimoles per mole (mmol/mol)\\] (both inclusive) as assessed by central laboratory on the day of screening.\n* Body mass index (BMI) greater than or equal to (\\>=) 25 kilograms per meter square (kg/m\\^2) on the day of screening.\n* Stable daily dose(s) greater than or equal to (\\>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens:\n* Any metformin formulations greater than or equal to (\\>=) 1500 milligrams (mg) or maximum tolerated or effective dose.\n* Any metformin combination formulation greater than or equal to (\\>=) 1500 mg or maximum tolerated or effective dose.\n\nThe treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors.\n\n• Treated with a once daily basal insulin (e.g. insulin glargine Unit 100 or U300, neutral protamine hagedorn (NPH) insulin, insulin detemir, insulin degludec) less than or equal to (\\<=) 40 units/day (U/day) for greater than or equal to (\\>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.\n\nExclusion Criteria:\n\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 nanomoles per litre (nmol/L) (or 260 picomoles per liter \\[pmol/L\\] \\[0.78 nanograms per millilitre {ng/mL}\\]) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening.\n* Presence or history of pancreatitis (acute or chronic).\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification.\n* Any episodes of diabetic ketoacidosis within 90 days before screening.\n* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8."}, 'identificationModule': {'nctId': 'NCT05514535', 'briefTitle': 'A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight', 'orgStudyIdInfo': {'id': 'NN9535-4801'}, 'secondaryIdInfos': [{'id': 'U1111-1267-0312', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2021-004392-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insuline glargine U100 (reduced) + semaglutide', 'description': 'Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).', 'interventionNames': ['Drug: Semaglutide', 'Drug: Insuline glargine U100 (reduced)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insuline glargine U100 (titrated)', 'description': 'Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).', 'interventionNames': ['Drug: Insuline glargine U100 (titrated)']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Participants will receive once-weekly semaglutide s.c. for 40 weeks. Semaglutide 0.25 mg will be given at week 0 and then the dose will be escalated at weeks 4, 8 and 12 to 0.5 mg, 1 mg, 2 mg respectively.', 'armGroupLabels': ['Insuline glargine U100 (reduced) + semaglutide']}, {'name': 'Insuline glargine U100 (reduced)', 'type': 'DRUG', 'description': 'Participants will receive insulin glargine U100 s.c. once-daily. Insulin glargine dose will be reduced by 10 U at initiation of semaglutide and then again at each semaglutide dose escalation up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).', 'armGroupLabels': ['Insuline glargine U100 (reduced) + semaglutide']}, {'name': 'Insuline glargine U100 (titrated)', 'type': 'DRUG', 'description': 'Participants will receive titrated insulin glargine U100 s.c. once-daily up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).', 'armGroupLabels': ['Insuline glargine U100 (titrated)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Lenzmeier Fam Med CCT Research', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'San Fernando Valley Hlth Inst, LLC', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Physicians Network', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clin Res San Diego', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'First Valley Medical Group', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda Univ Hlth Cr Endo', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Downtown LA Res Ctr. Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clin Res Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Wetlin Research Associates, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Res Inst. 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