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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00657319
First received: April 8, 2008
Last updated: June 5, 2012
Last verified: June 2012
  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 ] [ 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

  Eligibility

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.

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
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 ClinicalTrials.gov identifier: NCT00657319

Locations
Hungary
Budapest, Hungary, H-1025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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
ClinicalTrials.gov 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014