Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01548235
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

• Subjects with type 2 diabetes

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIAsp 30 users	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia

Secondary Outcome Measures

Name	Time	Method
Mean FPG (fasting plasma glucose)
Change from baseline in HbA1c (glycosylated haemoglobin)
Overall, daytime and nocturnal frequency of hypoglycaemic events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Copenhagen S, Denmark