| Trial ID: | L6809 |
| Source ID: | NCT00360698
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Insulin Glulisine in Type 2 Diabetic Patients
|
| Acronym: |
Basal Plus
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00360698/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine|DRUG: Glimepiride|DRUG: Insulin Glulisine|DRUG: Metformin
|
| Outcome Measures: |
Primary: Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%, Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%, at the end of treatment (week 24) | Secondary: Glycosylated Haemoglobin (HbA1c) Value, at the end of treatment (week 24)|Change in Glycosylated Haemoglobin (HbA1c) Value, from baseline to the end of treatment (week 24)|Daily Mean Plasma Glucose, at the end of treatment (week 24)|Change in Daily Mean Plasma Glucose, from baseline to the end of treatment (week 24)|Change in Weight, from baseline to the end of treatment (week 24)|Daily Dose of Insulin Glargine, Mean of 3 daily doses reported during the week prior to the final visit, at the end of treatment (week 24)|Daily Dose of Insulin Glulisine, Mean of 3 daily doses reported during the week prior to the final visit, at the end of treatment (week 24)|Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL, during treatment period (12 weeks)|Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL, during treatment period (12 weeks)|Rate of Severe Symptomatic Hypoglycemia, during treatment period (12 weeks)
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
106
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-07
|
| Completion Date: |
2008-08
|
| Results First Posted: |
2009-12-02
|
| Last Update Posted: |
2011-08-08
|
| Locations: |
Sanofi-aventis, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis, Moscow, Russian Federation|Sanofi-aventis, Guildford, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00360698
|
