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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

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