Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Type 2 Diabetes for more than 6 months

• Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months

• Body Mass Index (BMI) less than or equal to 40 kg/m2

• HbA1c 7.0-11.0%

Exclusion Criteria:

• Treatment with short acting insulin(s) for longer than 10 days

• Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization

• Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months