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Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

biphasic insulin aspart 30

biphasic insulin aspart 50

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%

Exclusion Criteria:

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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dosing visit 1

Dosing visit 2

Arm Description

Outcomes

Primary Outcome Measures

The maximum insulin aspart concentration

Secondary Outcome Measures

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

tmaxGIR, time to maximum glucose infusion rate value

The area under the glucose infusion rate profile

Vital signs (blood pressure and pulse)

Adverse events

Full Information

NCT ID

NCT01620424

First Posted

June 13, 2012

Last Updated

January 4, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01620424

Brief Title

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

Official Title

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

April 2001 (Actual)

Study Completion Date

April 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dosing visit 1

Arm Type

Experimental

Arm Title

Dosing visit 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 50

Intervention Description

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

Primary Outcome Measure Information:

Title

The maximum insulin aspart concentration

Secondary Outcome Measure Information:

Title

The area under the insulin aspart curve

Title

tmax, the time to maximum insulin aspart concentration

Title

t½, terminal half-life

Title

The area under the glucose infusion rate (GIR) profile

Title

GIRmax, maximum glucose infusion rate value

Title

tmaxGIR, time to maximum glucose infusion rate value

Title

The area under the glucose infusion rate profile

Title

Vital signs (blood pressure and pulse)

Title

Adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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% Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR,1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

1000005

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

18165218

Citation

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.

Results Reference

result

PubMed Identifier

17697911

Citation

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.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

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