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

Condition(s) targeted: Diabetes Mellitus, Type I

Intervention: Insulin Detemir (Drug); Insulin Glargine (Drug); Insulin Aspart (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Per Clauson, MD, PhD, Study Director, Affiliation: Novo Nordisk A/S

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.

Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c after 1 year trial period

Secondary outcome:

Body Weight

Blood Glucose

Hypoglycemia

Adverse Events

Insulin Treatment Satisfaction

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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%

Exclusion Criteria:

- Proliferative retinopathy or maculopathy

- Recurrent major hypoglycaemia

- Impaired hepatic or renal function

- Cardiac problems or uncontrolled hypertension

Kuopio University Hospital, Kuopio, Finland

Centre Hospitalier Saint-Louis, La Rochelle, France

Krankenhaus Bethanien, Hamburg, Germany

´t Lange Land Ziekenhuis, Zoetermeer, Netherlands

Danderyds Sjukhus, Stockholm, Sweden

San Diego, California 92161, United States

Huntington Beach, California 92646, United States

San Francisco, California 94143, United States

Inglewood, California 90301, United States

Irvine, California 92618, United States

La Jolla, California 92037, United States

Anaheim, California 92801, United States

Melbourne, Florida 32901, United States

Vero Beach, Florida 32960, United States

Hollywood, Florida 33021, United States

Tampa, Florida 33613, United States

Winter Park, Florida 32789, United States

Atlanta, Georgia 30309, United States

Idaho Falls, Idaho 83404, United States

Chicago, Illinois 60607, United States

Topeka, Kansas 66606, United States

Detroit, Michigan 48235, United States

St. Louis, Missouri 63110, United States

Omaha, Nebraska 68131, United States

Las Vegas, Nevada 89109, United States

Brick, New Jersey 08724, United States

Berlin, New Jersey 08009, United States

Asheville, North Carolina 28801, United States

Philadelphia, Pennsylvania 19107, United States

Dallas, Texas 75235, United States

Houston, Texas 77030, United States

Dallas, Texas 75390-8858, United States

San Antonio, Texas 78229, United States

Starting date: October 2004
Last updated: January 17, 2006