Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00539448 |
Primary objective :
To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.
Secondary objective :
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: insulin glargine Drug: insulin glulisine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients. |
Enrollment: | 98 |
Study Start Date: | April 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
combination of insulin Glargine & insulin Glulisine as basal bolus regimen
|
Drug: insulin glargine
in combination with insulin Glulisine as bolus regimen
Drug: insulin glulisine
in combination with insulin Glargine as bolus regimen
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Bahrain | |
Sanofi-aventis administrative office | |
Manama, Bahrain | |
Kuwait | |
Sanofi-aventis administrative office | |
Kuwait City, Kuwait | |
Qatar | |
Sanofi-aventis Administrative Office | |
Doha, Qatar | |
United Arab Emirates | |
Sanofi-aventis administrative office | |
Dubai, United Arab Emirates |
Study Director: | Hisham - MAHMOUD, MD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LANTU_L_01578 |
Study First Received: | October 3, 2007 |
Last Updated: | September 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00539448 History of Changes |
Health Authority: | United Arab Emirates : Ministry of Health |
Metabolic Diseases Autoimmune Diseases Insulin glulisine Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Insulin |
Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Insulin glulisine Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases |
Insulin Pharmacologic Actions Hypoglycemic Agents Diabetes Mellitus, Type 1 Glargine Glucose Metabolism Disorders |