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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70

• Registration Number: NCT01538511
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-05
• Primary Completion: 2007-03-13
• Study Completion: 2007-03-13
• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-
BIAsp 70	biphasic insulin aspart 70	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma insulin concentration curve from 0 to 24 hours

Secondary Outcome Measures

Name	Time	Method
Area under the concentration curve of plasma insulin from 0 to 4 hours after meals
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
The maximum plasma glucose concentration observed from 0 to 4 hours after meals
Frequency of adverse events
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan