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

Phase 2

Completed

Interventions: Drug: biphasic insulin aspart 30
Drug: insulin degludec/insulin aspart

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mix30	biphasic insulin aspart 30	-
SIAC	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Rate of Major and Minor Hypoglycaemic Episodes	Week 0 to Week 6 + 5 days follow up	Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes	Week 0 to Week 6 + 5 days follow up	Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).

Secondary Outcome Measures

Name	Time	Method
Diastolic BP (Blood Pressure)	Week 0, Week 6	Values at baseline (Week 0) and at Week 6
Number of Treatment Emergent Adverse Events (AEs)	Week 0 to Week 6 + 5 days follow up	Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Change in Body Weight	Week 0, Week 6	Change from baseline in body weight after 6 weeks of treatment
Systolic BP (Blood Pressure)	Week 0, Week 6.	Values at baseline (Week 0) and at Week 6
Electrocardiogram (ECG) Worsening	Week 0, Week 6	The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.