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

Condition(s) targeted: Diabetes Mellitus, Type II

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 2 diabetes.

Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 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 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

Jorvi Hospital, Espoo, Finland

Polyclinique de Minguettes, Venissieux, France

Sykehuset Østfold Sarpsborg HF, Sarpsborg, Norway

Forskningsbyn Ideon, Beta 2, Lund, Sweden

Little Rock, Arkansas 72204, United States

Spring Valley, California 91978, United States

San Francisco, California 94143, United States

Inglewood, California 90301, United States

Santa Ana, California 92705, United States

Orlando, Florida 32804, United States

Melbourne, Florida 32901, United States

New Port Richey, Florida 34652, United States

Vero Beach, Florida 32960, United States

Boca Raton, Florida 33433, United States

Winter Park, Florida 32789, United States

Jacksonville, Florida 32205, United States

Athens, Georgia 30606, United States

Idaho Falls, Idaho 83404, United States

Topeka, Kansas 66606, United States

Omaha, Nebraska 68131, United States

Las Vegas, Nevada 89119, United States

Berlin, New Jersey 08009, United States

Asheville, North Carolina 28801, United States

Hermitage, Pennsylvania 16148, United States

Philadelphia, Pennsylvania 19107, United States

Dallas, Texas 75235, United States

Dallas, Texas 75246, United States

Dallas, Texas 75390-8858, United States

San Antonio, Texas 78229, United States

Norfolk, Virginia 23502, United States

Richmond, Virginia 23249, United States

Tacoma, Washington 98405, United States

Starting date: September 2004
Last updated: September 18, 2006