Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

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 I diabetes.

Key facts

Study ID

NCT00095082

Run by

Novo Nordisk A/S

People needed

447

Starts

2004-09-01

Expected to finish

2005-12-01

Last updated by the study team

2017-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes for at least 12 months
• Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
• HbA1c less than or equal to 11.0%

You may not qualify if…

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

Where it is running

• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — Inglewood, California, United States
• Novo Nordisk Investigational Site — Irvine, California, United States
• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Lake Mary, Florida, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Vero Beach, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Topeka, Kansas, United States
• Novo Nordisk Investigational Site — Hyattsville, Maryland, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — St Louis, Missouri, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States
• Novo Nordisk Investigational Site — Berlin, New Jersey, United States
• Novo Nordisk Investigational Site — Sea Girt, New Jersey, United States
• Novo Nordisk Investigational Site — Asheville, North Carolina, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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