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Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657319
First Posted: April 14, 2008
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This observational study is conducted in Europe. The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1C [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • General conditions (reason of switch, BMI, selected laboratory parameters, quality of care) [ Time Frame: 6 months ]

Enrollment: 3495
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.
Other Name: NovoMix® 30

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult with type 2 diabetes mellitus on premix insulin treatment.
Criteria

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months
  • Analogue premix administration for the last 6 months

Exclusion Criteria:

  • Known or suspected allergy to insulin aspart
  • Newly diagnosed diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657319


Locations
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Gerö L. Improvement in metabolic control in type 2 diabetic patients after switching from biphasic human insulin (BHI) to biphasic insulin aspart 30/70 (BIAsp 30): An observational study in Hungary. ADA American Diabetes Association 2009; Country: USA City: New Orleans

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00657319     History of Changes
Other Study ID Numbers: BIASP-1939
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: January 9, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, pork; isophane insulin, pork drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs


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