NCT01538511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jun 2006

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

February 20, 2012

Last Update Submit

October 4, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

BIAsp 70

EXPERIMENTAL
Drug: biphasic insulin aspart 70

BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 70DRUG

Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted

BIAsp 70
biphasic insulin aspart 30DRUG

Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted

BIAsp 30

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

June 5, 2006

Primary Completion

March 13, 2007

Study Completion

March 13, 2007

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

JP(1)