Clinical trial NCT01538511: Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-24
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the plasma insulin concentration curve from 0 to 24 hours
Secondary outcomes:
measure: Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
measure: Maximum plasma insulin concentration observed from 0 to 4 hours after meals
measure: Time to reach the maximum plasma insulin concentration from 0 to 4 hours after meals
measure: The 24-hour plasma insulin profile deviances in Japanese type 2 diabetic subjects
measure: Pre-meal plasma glucose concentration before meals
measure: Postprandial plasma glucose (PPPG) excursion from 0 to 4 hours after meals
measure: The maximum plasma glucose concentration observed from 0 to 4 hours after meals
measure: The time to reach the maximum plasma glucose concentration of observed from 0 to 4 hours after meals
measure: Average of plasma glucose concentration from 0 to 24 hours
measure: The area under the plasma C-peptide concentration curve from 0 to 24 hours derived from the 24-hour plasma C-peptide profile
measure: Frequency of hypoglycaemic episodes
measure: Frequency of adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: