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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00046501 |
The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Humulin N Drug: Humulin L Drug: Lispro |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Morning LANTUS v. Intermediate-Acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-Controlled, Open, Randomized, Gender-Stratified, Two-Arm, Parallel-Group Study |
Estimated Enrollment: | 250 |
Study Start Date: | November 2002 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 9 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HOE901/4030 |
Study First Received: | September 30, 2002 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00046501 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Glargine Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin, Isophane Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |