- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620424
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes
January 4, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dosing visit 1
|
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
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
|
Experimental: Dosing visit 2
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The maximum insulin aspart concentration
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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t½, terminal half-life
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tmax, the time to maximum insulin aspart concentration
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GIRmax, maximum glucose infusion rate value
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Vital signs (blood pressure and pulse)
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The area under the insulin aspart curve
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The area under the glucose infusion rate (GIR) profile
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tmaxGIR, time to maximum glucose infusion rate value
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The area under the glucose infusion rate profile
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (Actual)
April 1, 2001
Study Completion (Actual)
April 1, 2001
Study Registration Dates
First Submitted
June 13, 2012
First Submitted That Met QC Criteria
June 13, 2012
First Posted (Estimate)
June 15, 2012
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
January 4, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Biphasic Insulins
- Insulin aspart, insulin aspart protamine drug combination 30:70
Other Study ID Numbers
- BIASP-1356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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