Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

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 the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.

Official Title
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An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1 HbA1c at least 7.0 % - maximum 11 % at screening Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed) An antidiabetic regimen that has been stable for at least 3 months prior to screening An antidiabetic regimen that includes a minimum of 2 OADs OADs dosed at least 50% of the maximum recommended dose Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) The receipt of any investigational medicinal product within one month prior to this trial Suffer from a life threatening disease (cancer) Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit) Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females Recurrent hypoglycaemia or hypoglycaemic unawareness Anemia (haemoglobin below 10 mg/dl)

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: Pre-breakfast BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms<br>|
| Experimental: Pre-dinner BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 | Estimated mean change from baseline in HbA1c after 11 weeks of treatment | Week 0, Week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 | Estimated mean change from baseline in FPG after 36 weeks of treatment | Week 0, Week 36 | 
| Number of Treatment Emergent Hypoglycaemic Episodes | A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product. | Week 0 to Week 36 |