Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT01527539
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11-23
• Primary Completion: 2004-10-12
• Study Completion: 2004-10-12
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Completed the BIAsp-1237 trial

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
HbA1c

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events
Occurence of hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇦 Windsor, Canada