Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With 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 compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Official Title
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A Single-Centre, Randomised, Open-Labelled, Two-Period, Crossover Trial In Subjects With Type 2 Diabetes Comparing the Glycaemic Control of Two Treatment Regimens: A Thrice Daily Regimen With Biphasic Insulin Aspart 70 and - 30 and a Twice Daily Regimen With Biphasic Human Insulin 30

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 70
* Drug: biphasic human insulin 30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Type 2 diabetes Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months HbA1c maximum 10.0% BMI (Body Mass Index) maximum 35.0 kg/m2 Able and willing to perform self-blood glucose monitoring (SBGM) Exclusion Criteria: The receipt of any investigational drug within the last 30 days prior to this trial Total daily insulin dose minimum 2.0 U/(kg·day) A history of drug abuse or alcohol dependence within the last 5 years Impaired hepatic function Impaired renal function Cardiac disease Severe, uncontrolled hypertension

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: biphasic insulin aspart 30<br>* Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period<br>Drug: biphasic insulin aspart 70<br>* Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period<br>Drug: biphasic human insulin 30<br>* Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period<br>|
| Active Comparator: Treatment period 2<br> | Drug: biphasic insulin aspart 30<br>* Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period<br>Drug: biphasic insulin aspart 70<br>* Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period<br>Drug: biphasic human insulin 30<br>* Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose average in 24-hour blood glucose profiles |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-meal glucose level |  |  | 
| Post-meal excursion of glucose (0-4 hours) |  |  | 
| Cmax, maximum concentration of total insulin |  |  | 
| tmax, time of maximum concentration of total insulin |  |  | 
| The area under the 24-hour total insulin concentration time curve |  |  | 
| Adverse events |  |  |