Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).

Official Title
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An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30
* Drug: biphasic insulin aspart 30
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756 HbA1c above or equal to 7.0% Body Mass Index (BMI) below or equal to 40.0 kg/m2 Exclusion Criteria: Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756 Known proliferative retinopathy or maculopathy requiring acute treatment Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: BIAsp 30 (2:1)<br>After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals | Drug: biphasic insulin aspart 30<br>* Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.<br>Drug: metformin<br>* Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged<br>|
| Experimental: BIAsp 30 (1:1)<br>After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals | Drug: biphasic insulin aspart 30<br>* Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.<br>Drug: metformin<br>* Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline |  | Week 0, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-point SMPG (Self Measured Plasma Glucose) Profile | A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day | Week 16 | 
| Percentage of Subjects Achieving HbA1c Below 7.0% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment | Week 16 | 
| Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% | The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment | Week 16 | 
| Number of Treatment Emergent Hypoglycaemic Episodes | Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included). | Weeks 0-16 |