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

Study Overview
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Brief Summary
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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.

Official Title
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A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin degludec
* Drug: insulin detemir
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIBA<br> | Drug: insulin degludec<br>* The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime<br>Drug: insulin aspart<br>* Injection subcutaneously immediately before each meal.<br>|
| Active Comparator: Insulin Detemir<br> | Drug: insulin detemir<br>* Injection subcutaneously at bedtime<br>Drug: insulin aspart<br>* Injection subcutaneously immediately before each meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major and Minor Hypoglycaemic Episodes | 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. | Week 0 to Week 6 + 5 days follow up | 
| Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | 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). | Week 0 to Week 6 + 5 days follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Adverse Events (AEs) | 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. | Week 0 to Week 6 + 5 days follow up | 
| Change in Body Weight | Observed change from baseline in body weight after 6 weeks of treatment | Week 0, Week 6 | 
| Electrocardiogram (ECG) | 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. | Week 0, Week 6 | 
| Diastolic Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Week 0, Week 6 | 
| Systolic Blood Pressure (BP) | Mean values at baseline (Week 0) and at Week 6 | Week 0, Week 6 |