Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00318786

BIASP-1598

JapicCTI-060241 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Enrollment: 289 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 2 diabetes
• Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
• HbA1c at least 7.5% and below 10.0%

Exclusion criteria

• Proliferative retinopathy or maculopathy requiring acute treatment
• Impaired hepatic and/or renal function
• Cardiac diseases
• Uncontrolled hypertension
• Known hypoglycemia unawareness or recurrent major hypoglycemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)