Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

Completed

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

• Registration Number: NCT01486875
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1155

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	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Incidence of major hypoglycaemic events	Week 26
Incidence of serious adverse drug reactions (SADRs)	Week 26

Secondary Outcome Measures

Name	Time	Method
Number of all hypoglycaemic events	In the 4 weeks prior to week 12 and week 26, respectively
HbA1c (glycosylated haemoglobin A1c)	Week 26
Fasting Plasma Glucose (FPG)	Week 26

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Lund, Sweden