Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart

Drug: biphasic human insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617565

BIASP-1536

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

Enrollment

219 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 or 2 diabetes for at least 3 months
Stabilised on current treatment with premixed human insulin for at least 4 weeks
Body mass index (BMI) between 18-40 kg/m2
HbA1c below 13.0%
Able and willing to perform self-blood glucose monitoring

Exclusion criteria

The receipt of any investigational drug within the last three months prior to this trial
Has a history of drug abuse or alcohol dependence within the last 5 years
Active proliferative retinopathy requiring laser or surgical intervention within the last year
Recurrent major hypoglycaemia as judged by the Investigator
Known or suspected allergy to trial product or related product