Clinical Trial Details
| Trial ID: | L3971 |
| Source ID: | NCT01127269 |
| Associated Drug: | Insulin Glargine |
| Title: | Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes |
| Acronym: | AFICIONADO |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: INSULIN GLARGINE |
| Outcome Measures: | Primary: Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode., From week 0 (baseline) to week 24 (end of study) | Secondary: Glycosylated Haemoglobin (HbA1c), From week 0 (baseline) to week 24 (end of study)|Dose and timing of insulin glargine, From week 0 (baseline) to week 24 (end of study)|Hypoglycemic episodes, From week 0 (baseline) to week 24 (end of study) |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 178 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2010-05 |
| Completion Date: | 2013-06 |
| Results First Posted: | |
| Last Update Posted: | 2014-07-17 |
| Locations: | Investigational Site Number 10, C.a.b.a., C1050AAK, Argentina|Investigational Site Number 14, C.a.b.a., C1419AHN, Argentina|Investigational Site Number 01, C.a.b.a., Argentina|Investigational Site Number 11, C.a.b.a., Argentina|Investigational Site Number 12, C.a.b.a., Argentina|Investigational Site Number 17, C.a.b.a., Argentina|Investigational Site Number 9, C.a.b.a., Argentina|Investigational Site Number 03, Caba, Argentina|Investigational Site Number 06, Caba, Argentina|Investigational Site Number 15, Caba, Argentina|Investigational Site Number 16, Caba, Argentina|Investigational Site Number 18, Caba, Argentina|Investigational Site Number 26, Capital Federal, Argentina|Investigational Site Number 22, Mar del Plata, 7600, Argentina|Investigational Site Number 13, Mar del Plata, B7602CBM, Argentina|Investigational Site Number 02, Mar del Plata, Argentina|Investigational Site Number 021, Moreno -Pcia. de Bs. As.-, Argentina|Investigational Site Number 07, Morón, Argentina|Investigational Site Number 04, Paraná, Argentina|Investigational Site Number 8, Salta, Argentina|Investigational Site Number 05, Sarandí, Argentina|Investigational Site Number 20, Tandil, 7000, Argentina|Investigational Site Number 25, Zárate, 2800, Argentina |
| URL: | https://clinicaltrials.gov/show/NCT01127269 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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