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Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01542450
First received: February 24, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 24, 2012
February 24, 2012
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 [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • AUCGIR, area under the glucose infusion rate value curve [ Designated as safety issue: No ]
  • GIRmax, the maximum GIR value [ Designated as safety issue: No ]
  • tmax GIR, time to maximum GIR value [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • Area under the curve [ Designated as safety issue: No ]
  • tmax, time to maximum concentration [ Designated as safety issue: No ]
  • MRT, mean residence time [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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
Not Provided

*   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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01542450
NN304-1475, JapicCTI-R070015
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Kato Takahiro Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
February 2012

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