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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 30

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1000005
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIAsp 30	Drug: biphasic insulin aspart 30; Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
Experimental: BIAsp 70	Drug: biphasic insulin aspart 70; Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the plasma insulin concentration curve from 0 to 24 hours

Secondary Outcome Measures

Outcome Measure
Frequency of hypoglycaemic episodes
Frequency of adverse events
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2006
• Primary Completion (Actual): March 13, 2007
• Study Completion (Actual): March 13, 2007

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: February 20, 2012
• First Posted (Estimate): February 24, 2012

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: BIASP-1638