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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: April 8, 2008
Last updated: June 5, 2012
Last verified: June 2012
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 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 ] [ Designated as safety issue: No ]

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

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00657319

Budapest, Hungary, H-1025
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Peter Varnai, MD Novo Nordisk Hungary Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00657319     History of Changes
Other Study ID Numbers: BIASP-1939
Study First Received: April 8, 2008
Last Updated: June 5, 2012
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015