Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 glargi...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2005

Estimated Enrollment :

324 Patients enrolled

Trial Details

Trial ID

NCT00097084

Start Date

September 1 2004

End Date

December 1 2005

Last Update

January 27 2017

Active Locations (60)

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Page 1 of 15 (60 locations)

1

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States, 72204

2

Novo Nordisk Investigational Site

Inglewood, California, United States, 90301

3

Novo Nordisk Investigational Site

San Francisco, California, United States, 94143-0780

4

Novo Nordisk Investigational Site

Santa Ana, California, United States, 92705