Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 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; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00184574

BIASP-1440

Details and patient eligibility

About

This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

Enrollment: 603 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with insulin
• Currently treated with Metformin
• HbA1c: 7.5-12.0%

Exclusion criteria

• Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2
• Metformin contraindications according to local practice
• TZDs within 6 months prior to randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)