Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

Phase 4

Completed

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

• Registration Number: NCT01486862
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Type 2 diabetes mellitus for at least 12 months
• HbA1c between 7.5-14.5% (inclusive) at screening
• Insulin naïve
• An antidiabetic regimen that has been stable for at least 3 months prior to screening
• An antidiabetic regimen that includes a minimum of 2 OADs

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Exclusion Criteria

• Use of any insulin preparations within the past 6 months
• Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

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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
Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c
Total number of hypoglycemic events
Adverse events