Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart 70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30 (NN-X14Mix30) in healthy volunteers.

Official Title
-----------------
A Two-centre, Randomised, Open-labelled, Four-week, Parallel-group Pharmacokinetics Trial in Japanese Type 2 Diabetic Subjects Characterising the Insulin Profile of Thrice Daily Regimen With Biphasic Insulin Aspart 70 (NN2000-Mix70) With Reference to That of Twice Daily Regimen With Biphasic Insulin Aspart 30 (NN-X14Mix30) and Physiological Insulin Profile in Japanese Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 70
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SUBJECTS WITH TYPE 2 DIABETES Subjects with type 2 diabetes mellitus Current treatment using intermediate-acting, long-acting or pre-mixed/biphasic insulin preparation (including insulin analogues) in once or twice daily (before breakfast and dinner) treatment regimen for at least 12 weeks (a temporary use [maximum of one week in total] of rapid-acting human insulin will be allowed) Age between 20-69 years, both inclusive HbA1c (glycosylated haemoglobin A1c) below 9.0% Body Mass Index (BMI) 18.5-25.0 kg/m^2 Total daily insulin dose (per day) above 0.2 U or IU/kg body weight and below 1.0 U or IU/kg body weight HEALTHY VOLUNTEERS Japanese subjects with considered generally healthy based on medical history and physical examination Age between 20-29 years, both inclusive Body Mass Index (BMI) 18.5-25.0 kg/m^2 Subjects with normal glucose tolerance (NGT); defined as fasting plasma glucose below 110 mg/dL and 2-hour post OGTT (oral glucose tolerance test) plasma glucose below 140 mg/dL Exclusion Criteria: SUBJECTS WITH TYPE 2 DIABETES Proliferative retinopathy or maculopathy requiring acute treatment Impaired hepatic function Impaired renal function Serious cardiac diseases Uncontrolled hypertension Known hypoglycaemia unawareness or recurrent major hypoglycaemia Current treatment or expected at the screening to start treatment with systemic corticosteroids HEALTHY VOLUNTEERS Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) at the screening History or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders Subjects with a first-degree relative with diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

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 70<br> | Drug: biphasic insulin aspart 70<br>* Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted<br>|
| Experimental: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma insulin concentration curve from 0 to 24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration curve of plasma insulin from 0 to 4 hours after meals |  |  | 
| Maximum plasma insulin concentration observed from 0 to 4 hours after meals |  |  | 
| Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals |  |  | 
| The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects |  |  | 
| Pre-meal plasma glucose concentration before meals |  |  | 
| Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals |  |  | 
| The maximum plasma glucose concentration observed from 0 to 4 hours after meals |  |  | 
| The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals |  |  | 
| Average of plasma glucose concentration from 0 to 24 hours |  |  | 
| The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile |  |  | 
| Frequency of hypoglycaemic episodes |  |  | 
| Frequency of adverse events |  |  |