Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00097877
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-11-30
• Study First Submitted QC: 2004-11-30
• Study First Posted: 2004-12-01
• Study Start: 2005-01
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

Inclusion Criteria

• Type 2 Diabetes

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	After 24 weeks

Secondary Outcome Measures

Name	Time	Method
safety variables
8-point plasma glucose profile
other glycemic variables

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇷 Santurce, Puerto Rico