Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00097084
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-11-17
• Study First Submitted QC: 2004-11-17
• Study First Posted: 2004-11-18
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Type 2 diabetes for at least 12 months
• Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
• BMI of maximum 40 kg/m2
• HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion Criteria

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Impaired hepatic or renal function
• Cardiac problems or uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 1 year trial period

Secondary Outcome Measures

Name	Time	Method
Adverse events
Body weight
Hypoglycemia
Blood glucose
Insulin Treatment Satisfaction

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Ängelholm, Sweden