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Tracking Information | |||||
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First Received Date † | February 20, 2006 | ||||
Last Updated Date | July 29, 2008 | ||||
Start Date † | April 2004 | ||||
Current Primary Outcome Measures † |
serum insulin concentrations [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00297583 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Insulin Glulisine in Type 1 Diabetes Mellitus | ||||
Official Title † | A Single-Center, Randomized, Double-Blind, 3-Period Cross-Over Trial to Compare the Effect of Insulin Glulisine, Insulin Lispro and Unmodified Human Insulin on the Endogenous Glucose Production in Type 1 Diabetic Patients. | ||||
Brief Summary | The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects. The secondary objectives of the study were to assess:
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||
Condition † | Type 1 Diabetes Mellitus | ||||
Intervention † | Drug: Insulin Glulisine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | May 2004 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion criteria
Exclusion criteria
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00297583 | ||||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | ||||
Secondary IDs †† | |||||
Study Sponsor † | Sanofi-Aventis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Sanofi-Aventis | ||||
Verification Date | July 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |