Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2001-10-18
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Subjects with type 2 diabetes

• Subjects with insulin treated for at least 24 weeks

• HbA1c maximum 11.0%

• Body mass index (BMI) below 30.0 kg/m^2

• Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

• Recurrent severe hypoglycaemia

• Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year

• Impaired hepatic function

• Impaired renal function

• Cardiac diseases

• Uncontrolled hypertension

• Subjects with history of severe allergic or severe hypersensitive reactions

• Total daily insulin dose at least 100 IU

• Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks