NCT01620424

Brief Summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Feb 2001

Shorter than P25 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

February 1, 2001

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

June 13, 2012

Last Update Submit

January 4, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The maximum insulin aspart concentration

Secondary Outcomes (9)

  • The area under the insulin aspart curve

  • tmax, the time to maximum insulin aspart concentration

  • t½, terminal half-life

  • The area under the glucose infusion rate (GIR) profile

  • GIRmax, maximum glucose infusion rate value

  • +4 more secondary outcomes

Study Arms (2)

Dosing visit 1

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50

Dosing visit 2

EXPERIMENTAL
Drug: biphasic insulin aspart 30Drug: biphasic insulin aspart 50

Interventions

biphasic insulin aspart 30DRUG

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

Dosing visit 1Dosing visit 2
biphasic insulin aspart 50DRUG

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

Dosing visit 1Dosing visit 2

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • Duration of diabetes for at least 1 year
  • Body Mass Index (BMI) maximum 30.0 kg/m\^2
  • HbA1c maximum 10.0%

You may not qualify if:

  • Recurrent severe hypoglycaemia
  • Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated / untreated hypertension
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • Total daily insulin dose exceeding 40 IU
  • Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day
  • Treatment with OHAs or insulin preparations once a day later than noon
  • Subjects who smoke more than 15 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (2)

  • Tibaldi JT. Biphasic insulin aspart 70/30 three times a day in older patients with type 2 diabetes not achieving optimal glycemic control on a twice-daily regimen: a retrospective case series analysis from clinical practice. Adv Ther. 2007 Nov-Dec;24(6):1348-56. doi: 10.1007/BF02877782.

    PMID: 18165218RESULT

  • Hirao K, Maeda H, Urata S, Takisawa Y, Hirao S, Sasako T, Sasaki T. Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Clin Ther. 2007 May;29(5):927-934. doi: 10.1016/j.clinthera.2007.05.017.

    PMID: 17697911RESULT

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

February 1, 2001

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

JP(1)