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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00607087 |
Purpose
Primary: To assess the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.
Secondary:
To compare insulin glulisine, insulin aspart and insulin lispro on:
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: Insulin glulisine Drug: Insulin lispro Drug: Insulin aspart |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus |
| Estimated Enrollment: | 304 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Insulin glulisine
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
| 2: Active Comparator |
Drug: Insulin lispro
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
| 3: Active Comparator |
Drug: Insulin aspart
100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 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.
Contacts and Locations| United States, New Jersey | |
| Sanofi-aventis Administrative Office | |
| Bridgewater, New Jersey, United States | |
| Australia | |
| Sanofi-aventis Administrative Office | |
| Macquarie Park, Australia | |
| Austria | |
| Sanofi-aventis Administrative Office | |
| Vienna, Austria | |
| France | |
| Sanofi-aventis Administrative Office | |
| Paris, France | |
| Hungary | |
| Sanofi-aventis Administrative Office | |
| Budapest, Hungary | |
| Israel | |
| Sanofi-aventis Administrative Office | |
| Natanya, Israel | |
| Italy | |
| Sanofi-aventis Administrative Office | |
| Milan, Italy | |
| Korea, Republic of | |
| Sanofi-aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| Sanofi-aventis Administrative Office | |
| PE Gouda, Netherlands | |
| Spain | |
| Sanofi-aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-aventis Administrative Office | |
| Bromma, Sweden | |
| United Kingdom | |
| Sanofi-aventis Administrative Office | |
| Guildford Surrey, United Kingdom | |
| Study Director: | Bertrand Alexandre, MD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | APIDR_C_02083, EUDRACT # 2007-003579-38 |
| Study First Received: | January 23, 2008 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607087 History of Changes |
| Health Authority: | Sweden: Regional Ethical Review Board |
|
Metabolic Diseases Autoimmune Diseases Insulin glulisine Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Diabetes Mellitus Type 1 |
Insulin Hypoglycemic Agents Diabetes Mellitus, Type 1 Insulin, Asp(B28)- 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 LISPRO Pharmacologic Actions Insulin Hypoglycemic Agents Diabetes Mellitus, Type 1 Insulin, Asp(B28)- Glucose Metabolism Disorders |