| Trial ID: | L3969 |
| Source ID: | NCT00941369
|
| Associated Drug: |
Insulin Glargine (Hoe901)/Nph Insulin
|
| Title: |
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine (HOE901)/NPH Insulin
|
| Outcome Measures: |
Primary: Health Assessment, Patient treatment satisfaction and Quality-of-Life, At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint) | Secondary: Glycaemic parameters assessment, At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)|Anteropometric data (Weight, waist circumference) assessment, At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)|Lipid assessment, At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)|Hypoglycemia assessment, Throughout the study from starting until the week 48
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
345
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2012-11-22
|
| Locations: |
Sanofi-Aventis Administrative Office, Berlin, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00941369
|
