Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2003-05-15
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

• 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, Globin Zinc

Criteria

Inclusion Criteria:

• Type 2 diabetes for at least 24 months

• Insulin treatment for the pase 3 months

• HbA1c (glycosylated haemoglobin) below 13%

• BMI (Body Mass Index) below 40 kg/m^2

• Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria:

• Receipt of any investigational drug within 4 weeks prior to this trial

• Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial

• Total daily insulin dosage less than or equal to 1.8 IU/kg