Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01704378
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04-18
• Primary Completion: 2003-03-14
• Study Completion: 2003-03-14
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Signed informed consent obtained before any trial-related activities
• Completed the trial BIAsp-1236

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Exclusion Criteria

• Planned changes in use of any prescription medication that may interfere with glucose regulation
• Known or suspected allergy to trial products or related products
• Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
• Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIAsp	biphasic insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Number of Hypoglycaemic episodes
Occurrence of adverse events

Secondary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)
Prandial increment in blood glucose
7-point blood glucose profile

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Wirral, Merseyside, United Kingdom