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Clinical Trial Details

Trial ID: L1913
Source ID: NCT04196231
Associated Drug: Ideglira
Title: Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)
Acronym: BEYOND
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: IDegLira|DRUG: IGlarLixi|DRUG: Insulin/Canaglifozin|DRUG: Insulin/Dapaglifozin|DRUG: Insulin/Empaglifozin|DRUG: Basal Bolus
Outcome Measures: Primary: Hba1c change, HbA1c group difference at 6 months, 6 months, 9 months, 12 months|Proportions of patients with significant HbA1c change, Proportions of patients undergoing a reduction equal or higher than 0.5% as compared with baseline levels during the follow up, Baseline, 3 months, 6 months, 9 months, 12 months, 18 months | Secondary: Weight Change, Baseline, 6 months, 18 months|BMI Change, Baseline, 6 months, 18 months|Waist circumference change, Baseline, 6 months, 18 months|Blood pressure change, Baseline, 6 months, 18 months|Fasting glycemia change, Baseline, 6 months, 18 months|Post-prandial glycemia change, Baseline, 6 months, 18 months|C-peptide change, Baseline, 6 months, 18 months|Change in total daily insulin dose, Baseline, 6 months, 18 months|Change in lipide profile, Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Baseline, 6 months, 18 months|Change in eGFR, Baseline, 6 months, 18 months|Diabetes treatment satisfaction, In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time)., Baseline, 6 months, 18 months
Sponsor/Collaborators: Sponsor: University of Campania Luigi Vanvitelli
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 258
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-11-27
Completion Date: 2020-10-20
Results First Posted:
Last Update Posted: 2020-10-22
Locations: Unit of Endocrinology and Metabolic Diseases, Naples, 80138, Italy
URL: https://clinicaltrials.gov/show/NCT04196231