| Trial ID: | L2383 |
| Source ID: | NCT00964574
|
| Associated Drug: |
Insulin Glulisine (Hmr1964)
|
| Title: |
Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus
|
| Acronym: |
PORTAL 1
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: INSULIN GLULISINE (HMR1964)|DRUG: INSULIN GLARGINE
|
| Outcome Measures: |
Primary: Mean change in Glycosylated haemoglobin (HbA1c), Week 12 | Secondary: Mean Glycosylated haemoglobin (HbA1c), Week 12|Mean Fasting Blood Glucose and mean Post Prandial Glycemia, Week 12|Number of documented symptomatic hypoglycaemic episodes, From week 0 to week 12|Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline, week 12|Mean change of Fasting Blood Glucose and Post Prandial Glycemia, From week 0 to week 12
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
68
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-07
|
| Completion Date: |
2010-07
|
| Results First Posted: |
|
| Last Update Posted: |
2012-07-17
|
| Locations: |
Sanofi-Aventis Administrative Office, Minsk, Belarus
|
| URL: |
https://clinicaltrials.gov/show/NCT00964574
|
