Clinical Trial Details
| Trial ID: | L2541 |
| Source ID: | NCT00272012 |
| Associated Drug: | Insulin Glulisine |
| Title: | OPAL - Insulin Glulisine, Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type 2 |
| Interventions: | DRUG: Insulin glulisine |
| Outcome Measures: | Primary: Change in HbA1c., from baseline to study endpoint. | Secondary: Change of pre-, 2 h postprandial and nocturnal blood glucose values, 8-point profile|Fasting blood glucose, 8-point blood glucose profile values|Responder rate HbA1c smaller 7 %, at study endpoint|Insulin dose, rapid-acting, basal and total daily doses|Weight, BMI, study follow-up|Hypoglycemic events, study follow-up|Adverse events., study follow-up |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 396 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2004-07 |
| Completion Date: | |
| Results First Posted: | |
| Last Update Posted: | 2009-12-07 |
| Locations: | Sanofi-Aventis, Berlin, Germany |
| URL: | https://clinicaltrials.gov/show/NCT00272012 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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