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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic human insulin 50; Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01650129

BIASP-1352

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

BIAsp

Experimental group

Treatment:

Drug: biphasic insulin aspart 50

BHI

Experimental group

Treatment:

Drug: biphasic human insulin 50