Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Official Title
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Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin aspart
* Device: biphasic insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Duration of type 2 diabetes for at least 6 months since diagnosis Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily BMI below 40 kg/m2 HbA1c between 7-12% Able and willing to perform self-monitoring of capillary blood glucose Exclusion Criteria: Current antidiabetic treatment with combination of three or more oral antidiabetic drugs Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed) Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator Known or suspected allergy to trial product or related products Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures Receipt of any investigational drug within 4 weeks prior to this trial Previous participation in 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

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin aspart|nan|
|Device: biphasic insulin aspart|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycaemic episodes |  |  | 
| Adverse events |  |  | 
| Difference of HbA1c change between the two groups |  | after 13 weeks of treatment | 
| Fasting plasma glucose of treatment |  | after 13 and 26 weeks | 
| Change in weight |  |  |