Clinical Trial Details
| Trial ID: | L5470 |
| Source ID: | NCT04945070 |
| Associated Drug: | Iglarlixi |
| Title: | INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi |
| Acronym: | IDEAL |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Treated With Insulin |
| Interventions: | DRUG: IGlarLixi|DRUG: MDI - Multiple dose insulin injection |
| Outcome Measures: | Primary: HbA1C, The effect of the transition from MDI regimen to IGlarLixi on HbA1c values, 6 months | Secondary: Hypoglycemia, Number and time in hypoglycemia, 6 months|Compliance, Adherence to treatment and recommended SMBG pattern, 6 months|Fasting plasma glucose, 6 months|Postprandial plasma glucose, 6 months|Glycemic variability, Measured from continuous glucose monitoring, 6 months|Time in target range of 3.9-10 mmol/l, Measured from continuous glucose monitoring, 6 months|Body weight, Change in body weight, 6 months|Treatment Satisfaction, Assessment of quality of life using Diabetes Treatment Satisfaction Questionnaire, 6 months | Other: ALT, Marker of hepatic steatosis, 6 months|hsCRP, Marker of low-grade inflammation, 6 months |
| Sponsor/Collaborators: | Sponsor: Institute for Clinical and Experimental Medicine |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 96 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2021-07 |
| Completion Date: | 2023-06 |
| Results First Posted: | |
| Last Update Posted: | 2021-07-22 |
| Locations: | Institute for Clinical and Experimental Medicine, Prague, Czechia |
| URL: | https://clinicaltrials.gov/show/NCT04945070 |
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