Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted
DRUGbiphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma insulin concentration curve from 0 to 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Area under the concentration curve of plasma insulin from 0 to 4 hours after meals | — |
| 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 | — |
| Frequency of adverse events | — |
| The maximum plasma glucose concentration observed from 0 to 4 hours after meals | — |
Countries
Japan
Outcome results
None listed