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

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

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.

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