Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Official Title
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A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day Total daily insulin dose below 1.4 IU/Kg HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory) Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1 Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1 Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months Known proliferative retinopathy or maculopathy requiring treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Subject-driven titration<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.<br>|
| Active Comparator: Investigator-driven titration<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS). | Week 0, week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving HbA1c Below 7.0% |  | After 20 weeks of treatment | 
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% |  | After 20 weeks of treatment | 
| Change From Baseline in FPG (Fasting Plasma Glucose) |  | Week 0, week 20 | 
| Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) | Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms. | Week 0 to week 20 (inclusive). |