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

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

• Phase: Phase 3
• 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:

• Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months

• Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months

• Body mass index (BMI) below or equal to 35.0 kg/m^2

• HbA1c below or equal to 11.0%

Exclusion Criteria:

• Total daily insulin dose at least 1.4 IU/kg

• Treatment with oral hypoglycaemic agents within the month prior to inclusion

• Recurrent severe hypoglycaemia (as judged by the investigator)

• Active proliferative retinopathy

• Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)

• History of pancreatitis