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

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin detemir

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00274274

NN304-1657

2005-000319-87 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

373 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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