Clinical Trial Details
| Trial ID: | L5169 |
| Source ID: | NCT03389490 |
| Associated Drug: | Insulin Glargine 300 Unt/Ml |
| Title: | Toujeo Versus NPH Self-titration Study |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Insulin Glargine 300 UNT/ML|DRUG: Neutral protamine hagedorn insulin |
| Outcome Measures: | Primary: Glycemic variability, Standard deviation of glucose from continuous glucose monitoring, 24 weeks | Secondary: Glycemic variability, Mean Amplitude of Glycemic excursions and Means of Daily Differences, 24 weeks|Percentage time in target, Percentage of time \<3.0mmol/L and \>10.0mmol/L, 24 weeks|Glycated haemoglobin, HbA1c, 24 weeks|Fasting blood glucose, FPG, 24 weeks|Incidence of hypoglycemia, Overall incidence of hypoglycemia and nocturnal hypoglycemia, 24 weeks|Proportion of patients achieving HbA1c <7.0%, Proportion of patients achieving HbA1c \<7.0% at week 24 without confirmed hypoglycemia, 24 weeks|Treatment satisfaction, ITSQ questionnaire, 24 weeks|Inflammatory markers, change in hs C reactive protein, 24 weeks|Heart rate variability, Change in heart rate variability, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Elaine Chow | Collaborators: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 50 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-01-01 |
| Completion Date: | 2020-05-01 |
| Results First Posted: | |
| Last Update Posted: | 2021-08-03 |
| Locations: | Prince of Wales Hospital, Hong Kong, Shatin, Hong Kong |
| URL: | https://clinicaltrials.gov/show/NCT03389490 |
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