Clinical Trial Details
| Trial ID: | L3142 |
| Source ID: | NCT04726657 |
| Associated Drug: | Premixed Human Isophane Insulin Suspension + Human Insulin Injection |
| Title: | Comparison of Two Biphasic Insulin Regimens |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Premixed Human Isophane Insulin Suspension + Human Insulin Injection|DRUG: Premixed Insulin |
| Outcome Measures: | Primary: Change in average blood glucose, average blood glucose (mg/dl) from continuous glucose monitoring, 7 days|Glycated Albumin, levels of glycated albumin (%) in serum, 7 days|Fructosamine, levels of fructosamine (μmol/L) in serum, 7 days | Secondary: Daily Insulin requirements, change in total daily dose of insulin (u), 7 days|nocturnal average blood glucose, change in nocturnal average blood glucose, 7 days|Time in range, change in time in range (% and minutes) from continuous glucose monitoring, 7 days|time above 180, change in time above 180 (% and minutes) from continuous glucose monitoring, 7 days|time below 70, change in time below 70 (% and minutes) from continuous glucose monitoring, 7 days |
| Sponsor/Collaborators: | Sponsor: Aristotle University Of Thessaloniki | Collaborators: University Hospital Tuebingen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 36 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-01-18 |
| Completion Date: | 2020-02-03 |
| Results First Posted: | |
| Last Update Posted: | 2021-01-27 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT04726657 |
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