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

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. Identifier: NCT00657319
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30

Study Type : Observational
Actual Enrollment : 3495 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. HbA1C [ Time Frame: 6 months ]

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

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.

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

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 identifier (NCT number): NCT00657319

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

Additional Information:
Publications of Results:
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 Identifier: NCT00657319     History of Changes
Other Study ID Numbers: BIASP-1939
First Posted: April 14, 2008    Key Record Dates
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 Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs