| Trial ID: | L4590 |
| Source ID: | NCT01169818
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus
|
| Acronym: |
ATLAS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine
|
| Outcome Measures: |
Primary: Change (decrease) in mean hemoglobin glycosylated (HbA1c) level, from week 0 (baseline) to week 24 (end of study) | Secondary: Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia, from week 0 (baseline) to week 24 (end of study)|Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%), from week 0 (baseline) to week 24 (end of study)|Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%., from week 0 (baseline) to week 24 (end of study)|Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG), from week 0 (baseline) to week 24 (end of study)|Evolution of Blood Glucose profiles, from week 0 (baseline) to week 24 (end of study)|Incidence of symptomatic hypoglycemia, from week 0 (baseline) to week 24 (end of study)|Incidence of nocturnal hypoglycemia, from week 0 (baseline) to week 24 (end of study)|Incidence of asymptomatic hypoglycemia, from week 0 (baseline) to week 24 (end of study)|Mean change in body weight in patients, from week 0 (baseline) to week 24 (end of study)|Mean insulin dose, from week 0 (baseline) to week 24 (end of study)|PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions), from week 0 (baseline) to week 24 (end of study)
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
555
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-08
|
| Completion Date: |
2012-06
|
| Results First Posted: |
|
| Last Update Posted: |
2013-07-08
|
| Locations: |
Administrative office, Shanghai, China|Administrative office, Mumbai, India|Administrative office, Tokyo, Japan|Administrative office, Karachi, Pakistan|Administrative office, Makati City, Philippines|Administrative office, Moscow, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT01169818
|
