Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec/insulin aspart

Drug: biphasic insulin aspart 30

Study type

Interventional

Funder types

Industry

Identifiers

NCT00842361

NN5401-3570

JapicCTI-090712 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

Enrollment

66 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with type 2 diabetes mellitus
Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
HbA1c below 10.0%
Body Mass Index (BMI) < 30.0 kg/m^2

Exclusion criteria

Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment with total insulin dose of more than 100 U or IU/day
Current treatment or expected to start treatment with systemic corticosteroid
Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening