A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Study Overview
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Brief Summary
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This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Official Title
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A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Conditions
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Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1) Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors HbA1c 7.0% - 10.0% Body mass index (BMI) less than or equal to 40.0 kg/m^2 Exclusion Criteria: Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty Chronic disorder or disease which might jeopardise safety or compliance Malignant neoplasms Recurrent severe hypoglycaemia

Ages Eligible for Study
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Minimum Age: 18 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 BID+/-OADs<br> | Drug: insulin degludec/insulin aspart<br>* Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.<br>|
| Experimental: IDeg OD plus IAsp +/-OADs<br> | Drug: insulin degludec<br>* Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.<br>Drug: insulin aspart<br>* Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (%) | Change from baseline in HbA1c (%) after 26 weeks of treatment | Week 0, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment | Week 0, week 26 | 
| Number of Treatment Emergent Hypoglycaemic Episodes | According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL)) | During Weeks 0-26 | 
| Number of Treatment Emergent Hypoglycaemic Episodes | According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia | During Weeks 0-26 | 
| Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. | Weeks 0-26 | 
| Incidence of Treatment Emergent Adverse Events (TEAE) | A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment | Weeks 0-26 |