Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control 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 trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Official Title
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Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: biphasic insulin aspart 30
* Drug: metformin
* Drug: biphasic insulin aspart 50


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive) FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive) Exclusion Criteria: Metformin contraindications according to local practice Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

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: BIAsp 50-50-30<br>Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin | Drug: biphasic insulin aspart 30<br>* Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner<br>Drug: metformin<br>* Tablets, 500 - 2000 mg, once, twice or three times daily<br>Drug: biphasic insulin aspart 50<br>* Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch<br>|
| Active Comparator: BIAsp 30-30<br>Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin | Drug: biphasic insulin aspart 30<br>* Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner<br>Drug: metformin<br>* Tablets, 500 - 2000 mg, once, twice or three times daily<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) | Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16) | week 0, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Achieving HbA1c Treatment Targets | The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%. | week 16 | 
| Change and Daily Average in 8-point Plasma Glucose | Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment. | week 0, week 16 | 
| Change and Daily Average in Prandial Plasma Glucose Increment | Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment. | week 0, week 16 | 
| The Total Increase in Total Daily Insulin Dose Per Body Weight | The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16). | week 0, week 16 | 
| Change in Body Weight | Change in body weight from baseline (week 0) to end of treatment (week 16) | week 0, week 16 | 
| Number of Hypoglycaemic Episodes | Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. | weeks 0-16 | 
| Number of Nocturnal Hypoglycaemic Episodes | Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. | weeks 0-16 |