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

Launched by NOVO NORDISK A/S · Feb 20, 2012

Keywords

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Gender

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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