Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.

Official Title
-----------------
A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Duration of diabetes for at least 1 year Body Mass Index (BMI) maximum 30.0 kg/m^2 HbA1c maximum 10.0% Exclusion Criteria: Recurrent severe hypoglycaemia Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks Impaired hepatic function Impaired renal function Cardiac problems Uncontrolled treated / untreated hypertension Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive Total daily insulin dose exceeding 40 IU Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day Treatment with OHAs or insulin preparations once a day later than noon Subjects who smoke more than 15 cigarettes per day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosing visit 1<br> | Drug: biphasic insulin aspart 30<br>* Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits<br>Drug: biphasic insulin aspart 50<br>* Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits<br>|
| Experimental: Dosing visit 2<br> | Drug: biphasic insulin aspart 30<br>* Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits<br>Drug: biphasic insulin aspart 50<br>* Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum insulin aspart concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the insulin aspart curve |  |  | 
| tmax, the time to maximum insulin aspart concentration |  |  | 
| t½, terminal half-life |  |  | 
| The area under the glucose infusion rate (GIR) profile |  |  | 
| GIRmax, maximum glucose infusion rate value |  |  | 
| tmaxGIR, time to maximum glucose infusion rate value |  |  | 
| The area under the glucose infusion rate profile |  |  | 
| Vital signs (blood pressure and pulse) |  |  | 
| Adverse events |  |  |