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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70

Study type

Interventional

Funder types

Industry

Identifiers

NCT01538511

BIASP-1638

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts 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