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 A/S
ClinicalTrials.gov Identifier:
NCT01620424
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 13, 2012
June 13, 2012
February 2001
April 2001   (final data collection date for primary outcome measure)
The maximum insulin aspart concentration [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 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
  • Experimental: Dosing visit 1
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic insulin aspart 50
  • Experimental: Dosing visit 2
    Interventions:
    • Drug: biphasic insulin aspart 30
    • Drug: biphasic insulin aspart 50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2001
April 2001   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01620424
BIASP-1356
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP