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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00311077 |
Primary objective
Secondary objective
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: Insulin Glulisine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects |
Study Start Date: | April 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria :
Exclusion criteria :
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HMR1964A/1502 |
Study First Received: | March 2, 2006 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00311077 History of Changes |
Health Authority: | Germany: Ethics Commission |
Obesity Hypoglycemic Agents Insulin glulisine Metabolic Diseases Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Healthy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Insulin glulisine Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |