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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00569400 |
This trial is conducted in Asia and Oceania.
The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: human insulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus |
Estimated Enrollment: | 220 |
Study Start Date: | May 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Queensland | |
Stones Corner, Queensland, Australia, 4120 | |
Hong Kong | |
Hong Kong, Hong Kong | |
Malaysia, Kuala Lumpur | |
Cheras, Kuala Lumpur, Malaysia, 56000 | |
New Zealand | |
Hamilton, New Zealand, NZ | |
Philippines, Metro Manila | |
Marikina City, Metro Manila, Philippines, 1800 |
Study Director: | Karsten Lyby, MSc Odont | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN729-1541 |
Study First Received: | December 5, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00569400 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Food Safety Authority; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Hong Kong: Department of Health |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |