Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Completed · Phase 4

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Key facts

Study ID

NCT00537303

Run by

Novo Nordisk A/S

People needed

296

Starts

2007-10-01

Expected to finish

2009-03-01

Last updated by the study team

2017-03-10

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus for more than 6 months
• HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
• BMI (Body Mass Index) less than 40 kg/m2
• Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
• Treatment with one to 3 OADs

You may not qualify if…

• Known or suspected allergy to trial products or related products
• Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
• Previous participation in any trial including this for the last 6 months
• Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Where it is running

• Novo Nordisk Investigational Site — Mission Viejo, California, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Athens, Georgia, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Des Moines, Iowa, United States
• Novo Nordisk Investigational Site — Lawrenceville, New Jersey, United States
• Novo Nordisk Investigational Site — Asheville, North Carolina, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Kettering, Ohio, United States
• Novo Nordisk Investigational Site — Greer, South Carolina, United States
• Novo Nordisk Investigational Site — Chattanooga, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States
• Novo Nordisk Investigational Site — Newport News, Virginia, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Milwaukee, Wisconsin, United States
• Novo Nordisk Investigational Site — Århus C, Denmark
• Novo Nordisk Investigational Site — Espoo, Finland
• Novo Nordisk Investigational Site — Oulu, Finland
• Novo Nordisk Investigational Site — Oulu, Finland
• Novo Nordisk Investigational Site — Tampere, Finland
• Novo Nordisk Investigational Site — Fresno, California, United States

Full record on ClinicalTrials.gov

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