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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01620424
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 50
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The maximum insulin aspart concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the insulin aspart curve [ Designated as safety issue: No ]
  • tmax, the time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • The area under the glucose infusion rate (GIR) profile [ Designated as safety issue: No ]
  • GIRmax, maximum glucose infusion rate value [ Designated as safety issue: No ]
  • tmaxGIR, time to maximum glucose infusion rate value [ Designated as safety issue: No ]
  • The area under the glucose infusion rate profile [ Designated as safety issue: No ]
  • Vital signs (blood pressure and pulse) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2001
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing visit 1 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
Drug: 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
Experimental: Dosing visit 2 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
Drug: 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620424

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620424     History of Changes
Other Study ID Numbers: BIASP-1356
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013