Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: insulin NPH; Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600626

BIASP-1486

Details and patient eligibility

About

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
• HbA1c between 8.0-10.5%
• Body mass index (BMI) below 35.0 kg/m2
• Able and willing to perform self-monitoring of blood glucose

Exclusion criteria

• Total daily insulin dose of 1.80 IU/kg or more
• Known or suspected allergy to trial product or related products
• Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)