Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

Official Title
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A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)

Conditions
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Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days) Exclusion Criteria: Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

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: IDegAsp OD<br> | Drug: insulin degludec/insulin aspart<br>* Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).<br>Drug: insulin glargine<br>* Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.<br>|
| Active Comparator: IGlar OD<br> | Drug: insulin glargine<br>* Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) | Observed change from baseline in HbA1c after 26 weeks of treatment | Week 0, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal | Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal | Week 26 | 
| Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. 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 26 + 7 days follow up | 
| Rate of Confirmed Hypoglycaemic Episodes | Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. | Week 0 to Week 26 + 7 days follow up | 
| Rate of Nocturnal Confirmed Hypoglycaemic Episodes | Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m. | Week 0 to Week 26 + 7 days follow up | 
| Change in Body Weight | Observed change from baseline in body weight after 26 weeks of treatment | Week 0, Week 26 |