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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-
BIAsp 70	biphasic insulin aspart 70	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma insulin concentration curve from 0 to 24 hours

Secondary Outcome Measures

Name	Time	Method
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
Frequency of adverse events
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

Recruitment & Eligibility