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Clinical Trials/NCT00657319
NCT00657319
Completed
Not Applicable

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

Novo Nordisk A/S1 site in 1 country3,495 target enrollmentStarted: October 2007Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 2
Interventionsbiphasic insulin aspart 30

Overview

Phase
Not Applicable
Status
Completed
Enrollment
3,495
Locations
1
Primary Endpoint
HbA1C
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Intervention: biphasic insulin aspart 30 (Drug)

Outcomes

Primary Outcomes

HbA1C

Time Frame: 6 months

Secondary Outcomes

  • General conditions (reason of switch, BMI, selected laboratory parameters, quality of care)(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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