Physiological Concept of Insulin Therapy in Subjects With Type 2 Diabetes

Completed

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

• Registration Number: NCT01536639
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of the study was to evaluate the safety and efficacy of biphasic insulin aspart 30 (NovoMix® 30) when switching to a modern premix insulin analogue treatment compared to previous insulin regimen in routine clinical practice in the Slovak Republic.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose (FPG)
Post-prandial glucose (PPG)
Weight
Hypoglycaemia
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia