Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

Completed

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

• Registration Number: NCT01565733
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-29
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2223

Inclusion Criteria

• Patients with type 2 diabetes
• Treated with oral anti-diabetics and/or human insulin

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Exclusion Criteria

• Persons previously included in the trial
• Hypersensitive to biphasic insulin aspart or any of the excipients
• Pregnant or lactating women, or those who plan to get pregnant within the next 12 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NovoMix® 30 users	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Frequency of severe hypoglycaemic episodes

Secondary Outcome Measures

Name	Time	Method
Number of severe hypoglycaemic episodes
Average plasma glucose level at bedtime and at night
Postprandial glucose concentration after breakfast, lunch, and dinner
Average fasting glucose concentration after waking and before main meals
Number of mild hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇱 Warszawa, Poland