Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Official Title
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A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve 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
* Drug: insulin glargine
* Drug: metformin
* Drug: glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months Ongoing stable treatment with metformin for at least 2 months Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months Insulin naive HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values) Exclusion Criteria: Metformin contraindication according to local practice TZD (thiazolidinedione) treatment for the last 5 months before trial start Systemic treatment with any corticosteroid 3 months before trial start Any disease or condition which according to the Investigator would interfere with the 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 30<br> | Drug: biphasic insulin aspart<br>* Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.<br>Drug: metformin<br>* Tablets, 2550 mcg. Administered once daily.<br>Drug: glimepiride<br>* Tablets 2 mg. 4, 6 or 8 mg administered once daily.<br>|
| Active Comparator: Glargine<br> | Drug: insulin glargine<br>* Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.<br>Drug: metformin<br>* Tablets, 2550 mcg. Administered once daily.<br>Drug: glimepiride<br>* Tablets 2 mg. 4, 6 or 8 mg administered once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin A1c (HbA1c) | Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment. | After 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-point Self-measured Plasma Glucose Profiles | Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. 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. | After 26 weeks of treatment | 
| Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) | The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin. | After 26 weeks of treatment | 
| Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) | Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. | After 26 weeks of treatment | 
| Number of Hypoglycaemic Episodes | Total number of hypoglycaemic episodes experienced in each treatment arm. 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 0-26 | 
| Number of Subjects Reporting Treatment Emergent Adverse Events | Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration. | Weeks 0-26 |