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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 |
| MedlinePlus related topics: | Diabetes Diabetes Type 1 |
| ChemIDplus related topics: | Insulin Insulin aspart Insulin lispro Insulin glulisine |
| 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: | 270 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | April 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| Contact: Public Registry GMA | PublicRegistryGMA@sanofi-aventis.com |
| United States, New Jersey | |||||
| Sanofi-aventis | Active, not recruiting | ||||
| Bridgewater, New Jersey, United States | |||||
| Australia | |||||
| Sanofi-aventis | Recruiting | ||||
| MacQuarie Park, Australia | |||||
| Austria | |||||
| Sanofi-aventis | Recruiting | ||||
| Wien, Austria | |||||
| France | |||||
| Sanofi-aventis | Recruiting | ||||
| Paris, France | |||||
| Hungary | |||||
| Sanofi-aventis | Not yet recruiting | ||||
| Budapest, Hungary | |||||
| Israel | |||||
| Sanofi-aventis | Recruiting | ||||
| Natanya, Israel | |||||
| Italy | |||||
| Sanofi-aventis | Not yet recruiting | ||||
| Milan, Italy | |||||
| Korea, Republic of | |||||
| Sanofi-aventis | Recruiting | ||||
| Seoul, Korea, Republic of | |||||
| Netherlands | |||||
| Sanofi-aventis | Recruiting | ||||
| Gouda, Netherlands | |||||
| Spain | |||||
| Sanofi-aventis | Recruiting | ||||
| Barcelona, Spain | |||||
| Sweden | |||||
| Sanofi-aventis | Recruiting | ||||
| Bromma, Sweden | |||||
| United Kingdom | |||||
| Sanofi-aventis | Recruiting | ||||
| Guildford, United Kingdom | |||||
| Sanofi-Aventis |
| 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 |
| First Received: | January 23, 2008 |
| Last Updated: | July 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00607087 |
| Health Authority: | Sweden: Regional Ethical Review Board |
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