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

• Status: Completed
• Trial end date: 2007-03-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

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