Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart

• Registration Number: NCT00704223
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-24
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

Inclusion Criteria

• Type 2 diabetes
• HbA1c over 7%
• No contraindication with NovoMix® 70

Exclusion Criteria

• Type 1 diabetes
• Subjects participating in a clinical trial or another observational study
• Subjects under previous basis-bolus insulin therapy
• Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart	-

Primary Outcome Measures

Name	Time	Method
number of major and minor hypoglycaemic events and adverse events	3 months

Secondary Outcome Measures

Name	Time	Method
HbA1c	3 months
PPBG	3 months
FBG	3 months