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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620424
• Other study ID #: BIASP-1356
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: January 4, 2017
• Start date: February 2001
• Est. completion date: April 2001

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
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
• biphasic insulin aspart 50
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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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, t — View 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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum insulin aspart concentration			No
Secondary	The area under the insulin aspart curve			No
Secondary	tmax, the time to maximum insulin aspart concentration			No
Secondary	t½, terminal half-life			No
Secondary	The area under the glucose infusion rate (GIR) profile			No
Secondary	GIRmax, maximum glucose infusion rate value			No
Secondary	tmaxGIR, time to maximum glucose infusion rate value			No
Secondary	The area under the glucose infusion rate profile			No
Secondary	Vital signs (blood pressure and pulse)			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk