Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Phase 2

Completed

Interventions: Drug: insulin degludec
Drug: insulin detemir
Drug: 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 or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Recruitment & Eligibility

Inclusion Criteria

Subjects with type 1 diabetes mellitus more than one year
Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
HbA1c below 10.0%
Body Mass Index (BMI) below 30.0 kg/m^2

Exclusion Criteria

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Rate of Major and Minor Hypoglycaemic Episodes	Week 0 to Week 6 + 5 days follow up	Observed 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	Observed 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 23:00-05:59 (both inclusive).

Secondary Outcome Measures

Name	Time	Method
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	Observed change from baseline in body weight after 6 weeks of treatment
Electrocardiogram (ECG)	Week 0, Week 6	The number of subjects having a 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.
Diastolic Blood Pressure (BP)	Week 0, Week 6	Mean values at baseline (Week 0) and at Week 6
Systolic Blood Pressure (BP)	Week 0, Week 6	Mean values at baseline (Week 0) and at Week 6