Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes
NCT ID: NCT01542450
Last Updated: 2017-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2002-08-31
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment period 1
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
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
Treatment period 2
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Tokyo, , Japan
Countries
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References
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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
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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JapicCTI-R070015
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN304-1475
Identifier Type: -
Identifier Source: org_study_id
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