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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00698126 |
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
Condition | Intervention |
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Diabetes Mellitus, Type 2 |
Drug: soluble human insulin Drug: biphasic insulin aspart |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Multicentre, Open Label, Nonrandomised, Non-Interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study |
Estimated Enrollment: | 3000 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
A |
Drug: soluble human insulin
Observational study; use of the products as in the normal clinical practice conditions
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B |
Drug: biphasic insulin aspart
Observational study; use of the products as in the normal clinical practice conditions
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | ANA-1897 |
Study First Received: | June 13, 2008 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00698126 History of Changes |
Health Authority: | Italy: Ethics Committee |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Insulin, Asp(B28)- |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |