Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00184574
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 603

Inclusion Criteria

• Type 2 diabetes
• Currently treated with insulin
• Currently treated with Metformin
• HbA1c: 7.5-12.0%

Exclusion Criteria

• Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
• Metformin contraindications according to local practice
• TZDs within 6 months prior to randomisation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HbA1c	after 36 weeks

Secondary Outcome Measures

Name	Time	Method
Safety variables
8-point plasma glucose profiles
Other glycemic variables

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Watford, United Kingdom