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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00046150 |
The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.
Condition | Intervention | Phase |
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Diabetes, Type I |
Drug: Insulin glulisine (HMR1964) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | 12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Informed consent must be obtained in writing for all subjects at enrollment into the study (see Section 12.3).
EXCLUSION CRITERIA:
Subjects presenting with any of the following will not be included in the study:
France | |
Hospital de Rangueil | |
Toulouse, France, 31403 | |
Germany | |
Sanofi-aventis Administrative Office | |
Berlin, Germany | |
Netherlands | |
Sanofi-aventis Administrative Office | |
Gouda, Netherlands |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | HMR1964/3006, HMR1964 |
Study First Received: | September 20, 2002 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00046150 |
Health Authority: | United States: Food and Drug Administration |
Insulin glulisine Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |