Clinical Trial Details
| Trial ID: | L5250 |
| Source ID: | NCT01079364 |
| Associated Drug: | Insulin Glulisine |
| Title: | Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting |
| Acronym: | BASAAL PLUS |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Insulin glulisine|DRUG: Insulin glargine|DRUG: Premixed insulin (Insulin Aspart 30/70 ) |
| Outcome Measures: | Primary: Glycosylated Haemoglobin (HbA1c) Value, Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients., at screening (week - 2), week 12 (if available) and 24|Self Measured Blood Glucose (SMBG), at Baseline (week 0), week 2, 12 and 24 | Secondary: DTSQs (Diabetes Treatment Satisfaction Questionnaire - status), at week 0, 12 and 24|DTSQc (Diabetes Treatment Satisfaction Questionnaire - change), at week 24|ITSQ (Insulin Treatment Satisfaction Questionnaire), at week 0, 12 and 24|Hypoglycemic events, at week 0, 2, 12 and 24|Adverse Events (excluding hypoglycemic events), at week - 2, 0, 2, 12 and 24 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 52 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2010-01 |
| Completion Date: | 2012-07 |
| Results First Posted: | |
| Last Update Posted: | 2013-05-29 |
| Locations: | Sanofi-Aventis Administrative Office, Gouda, Netherlands |
| URL: | https://clinicaltrials.gov/show/NCT01079364 |
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