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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50

• Registration Number: NCT01620424
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2001-04
• Study Completion: 2001-04
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dosing visit 1	biphasic insulin aspart 30	-
Dosing visit 2	biphasic insulin aspart 30	-
Dosing visit 1	biphasic insulin aspart 50	-
Dosing visit 2	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
The maximum insulin aspart concentration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan