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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)