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Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01542450
First received: February 24, 2012
Last updated: January 26, 2017
Last verified: January 2017
February 24, 2012
January 26, 2017
August 2002
February 2003   (Final data collection date for primary outcome measure)
The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Same as current
Complete list of historical versions of study NCT01542450 on ClinicalTrials.gov Archive Site
  • AUCGIR, area under the glucose infusion rate value curve
  • GIRmax, the maximum GIR value
  • tmax GIR, time to maximum GIR value
  • Cmax, maximum concentration
  • Area under the curve
  • tmax, time to maximum concentration
  • MRT, mean residence time
  • t½, terminal half-life
  • Adverse events
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus
This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin detemir
    Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
  • Drug: insulin NPH
    Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
  • Experimental: Treatment period 1
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin NPH
  • Active Comparator: Treatment period 2
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin NPH
Irie S, Matsumura Y, Hirano K. Pharmacokinetics and Pharmacodynamics of Single Dose Insulin Detemir, Long-acting soluble insulin analogue compared to NPH insulin in Patients with type 1 Diabetes Mellitus. Journal of Clinical Ther. and Med. 2007; 5 (23): 349-356

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 2003
February 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • HbA1c (glycosylated haemoglobin) maximum 9.0%
  • Duration of diabetes at least 1 year
  • Body Mass Index (BMI) maximum 25.0 kg/m^2

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
  • 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
  • Known or suspected allergy against the trial products or related products including the components
  • Previous history of serious allergy or anaphylactic reaction
  • Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results
  • Severe late-phase diabetic complications including nephropathy
  • Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks
  • Known or suspected alcohol and illicit substance abuse or dependence
  • Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant
  • The receipt of any investigational drug within the last 12 weeks prior to this trial
  • Current or anticipated treatment with systemic corticosteroids
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01542450
NN304-1475
JapicCTI-R070015 ( Registry Identifier: JAPIC )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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