An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

Completed

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

• Registration Number: NCT00696995
• 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 serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

• Patients with Type 2 diabetes
• Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria

• Patients who are unlikely to comply with the protocol
• Pregnancy or breastfeeding or intention of becoming pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
The number of serious adverse drug reactions, including major hypoglycaemic events	at 26 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c	at 12 weeks and 26 weeks
The number of all hypoglycaemic events	at 26 weeks
Fasting plasma glucose at visits	at 12 weeks and 26 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇮 Lahti, Finland