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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00593255 |
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Drug: soluble human insulin Drug: insulin aspart Drug: insulin NPH |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Efficacy and Safety of Insulin Aspart Plus NPH Insulin to Soluble Human Insulin + NPH Insulin in Diabetes Mellitus |
Enrollment: | 220 |
Study Start Date: | July 2004 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (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: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | ANA-1634 |
Study First Received: | January 2, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00593255 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin, Isophane Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |