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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00297583 |
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:
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Drug: Insulin Glulisine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
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. |
Study Start Date: | April 2004 |
Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contraindications from:
Cardiac problems:
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HMR1964A/1501 |
Study First Received: | February 20, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00297583 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
Metabolic Diseases Autoimmune Diseases Insulin glulisine Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Diabetes Mellitus Type 1 |
Insulin Hypoglycemic Agents Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Insulin glulisine Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |