| Trial ID: | L6978 |
| Source ID: | NCT01203111
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
|
| Acronym: |
CHANGING
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: INSULIN GLARGINE|DRUG: INSULIN GLULISINE
|
| Outcome Measures: |
Primary: Change in HbA1c level for patients with addition of glulisine at week 12, between week 12 and week 24 (end of treatment period) | Secondary: Percentage of patients with HbA1c level < 7%, at week 24 (end of treatment period)|Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event, at week 24 (end of treatment period)|Fasting Plasma Glucose, at week 0, week 12 and week 24|7-point Self Monitoring of Blood Glucose, at week 0, week 12 and week 24|Daily dose of insulin glargine, at week 24 (end of treatment period)|Daily dose of insulin glulisine, at week 24 (end of treatment period)|Systolic / diastolic blood pressure, heart rate, weight change, from week 0 (baseline) to week 24 (end of treatment period)|Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe), from week 0 (from baseline) to week 24 (end of treatment)
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
207
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-12
|
| Completion Date: |
2012-07
|
| Results First Posted: |
|
| Last Update Posted: |
2012-08-30
|
| Locations: |
Administrative office, Algiers, Algeria|Administrative office, Sao Paulo, Brazil|Administrative office, Natanya, Israel|Administrative office, Beirut, Lebanon|Administrative office, Col. Coyoacan, Mexico|Administrative office, Casablanca, Morocco|Administrative office, Lima, Peru|Administrative office, Jeddah, Saudi Arabia|Administrative office, Dubaï, United Arab Emirates|Administrative office, Caracas, Venezuela
|
| URL: |
https://clinicaltrials.gov/show/NCT01203111
|
