Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: insulin detemir<br>* 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<br>Drug: insulin NPH<br>* 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<br>|
| Active Comparator: Treatment period 2<br> | Drug: insulin detemir<br>* 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<br>Drug: insulin NPH<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |