Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600366

BIASP-1566

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Enrollment: 71 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Insulin naive diabetes
• Current treatment with OHA, secondary failure
• Body mass index (BMI) below 40 kg/m2
• HbA1c over 8.5%
• Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion criteria

• History of drug or alcohol abuse
• Receipt of the investigational drug within the last month prior to this trial
• Known or suspected allergy to trial products or related products
• Severe uncontrolled hypertension
• Any disease or condition, which the Investigator feels, would interfere with the trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)