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Clinical Trial Details

Trial ID: L5000
Source ID: NCT03899402
Associated Drug: Insulin
Title: Triple Therapy in T1DM
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Insulin|DRUG: Semaglutide|DRUG: Dapagliflozin|DRUG: Placebo to Dapagliflozin
Outcome Measures: Primary: Change in HbA1c following dapagliflozin, Change in HbA1c at 6 months following dapagliflozin or placebo therapy in addition to combined semaglutide and insulin treatment., 6 months | Secondary: Change in HbA1c with triple therapy, Change in HbA1c from baseline at 12 months in triple therapy group compared to insulin only group., 12 months|Change in HbA1c with semaglutide, Change in HbA1c from baseline at 6 months in dual therapy group (insulin and semaglutide) compared to insulin only group., 6 months|Assessment of hyperglycemia level 1, Change in percent Time hyperglycemia Level 1(180-250mg/dl) as assessed by CGM, 12 months|Assessment of hyperglycemia level 2, Change in percent Time in hyperglycemia Level 2 ( \>250mg/dl) as assessed by CGM, 12 months|Assessment of hypoglycemia, Change in percent Time in hypoglycemia Level 1 (54-70mg/dl) as assessed by CGM, 12 months|Assessment of percent time glucose in range, Change in percent Time in Range (70- 180 mg/dl) as assessed by CGM, 12 months|Fructosamine indices, Assessment of fructosamine, 12 months|Weekly fasting glucose indices, Assessment of change of weekly fasting glucose, 12 months|Insulin requirement indices, Assessment of the change in insulin requirement, 12 months|body weight assessment following dapagliflozin, Change in body weight at 6 months between dapagliflozin and placebo groups., 6 months|body weight assessment following semaglutide, Change in body weight at 6 months following starting semaglutide compared to standard of care (SOC) group., 6 months|body weight assessment following triple therapy, Change in body weight as assessed at 12 months on dapagliflozin and semaglutide compared to SOC therapy., 12 months|Systolic Blood pressure assessment after triple therapy, Anti-hypertensive effects including change in systolic BP on dapagliflozin and semaglutide compared to SOC therapy., 12 months|Diastolic Blood pressure assessment, Anti-hypertensive effects including change in diastolic BP on dapagliflozin and semaglutide compared to SOC therapy., 12 months|Blood pressure medication use, Anti-hypertensive effects including change in numbers of BP medications required in patients dapagliflozin and semaglutide compared to SOC therapy., 12 months|Level 2 hypoglycemia assessment, Differences in rates of hypoglycemic events Level 2 (\<54mg/dl) between triple therapy and in standard therapy arm., 12 months|Severe (level 3) hypoglycemia assessment, Differences in rates of hypoglycemic events Level 3 (\<54mg/dl) characterized by altered mental and/or physical status requiring assistance) between triple therapy and in standard therapy arm., 12 months|Level 1 hyperglycemia assessment, Differences in rates of Level 1 hyperglycemia (glucose levels \>180mg/dl and \<250mg dl) between triple therapy and in standard therapy arm., 12 months|Level 2 hyperglycemia assessment, Differences in rates of Level 2 hyperglycemia (glucose levels \<250mg dl) between triple therapy and in standard therapy arm., 12 months|serum ketones assessment, Differences in rates of diabetic ketoacidosis defined as elevated serum ketones (greater than the upper limit of the normal range) in investigative arms., 12 months|Urinary ketones assessment, Differences in rates of diabetic ketoacidosis defined as elevated urine ketones (greater than the upper limit of the normal range) in investigative arms., 12 months|Diabetic ketoacidosis assessment, Differences in rates of diabetic ketoacidosis defined as Blood pH \<7.3 in investigative arms., 12 months
Sponsor/Collaborators: Sponsor: State University of New York at Buffalo | Collaborators: University of Glasgow|Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 78
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-05-01
Completion Date: 2026-03-31
Results First Posted:
Last Update Posted: 2025-04-02
Locations: Diabetes and Endocrinology Research Center of WNY, Williamsville, New York, 14221, United States
URL: https://clinicaltrials.gov/show/NCT03899402