Comparing Insulin Aspart With Fast-acting Insulin Human 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 of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.

Official Title
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A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection 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 aspart
* Drug: insulin human
* Drug: insulin aspart
* Drug: insulin human


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Treated with multiple daily insulin injections for at least 12 months Current daily basal insulin requirement above or equal to 0.3 U/kg/day Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% Body Mass Index (BMI) 18.0-28.0 kg/m^2 Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening) Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening) Subject who smokes more than 10 cigarettes or the equivalent per day Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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 sequence 1 - IM treatment group<br> | Drug: insulin aspart<br>* At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.<br>|
| Experimental: Treatment sequence 2 - IM treatment group<br> | Drug: insulin human<br>* At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.<br>|
| Experimental: Treatment sequence 1 - IV treatment group<br> | Drug: insulin aspart<br>* At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.<br>|
| Experimental: Treatment sequence 2 - IV treatment group<br> | Drug: insulin human<br>* At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance at steady state (CLss) for IV treatment group |  | from 180 min to 240 min | 
| Area under the curve (AUC) for IM treatment group |  | from 0 to 480 min after intramuscular injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) for IM treatment group |  | from 0 minutes to infinite time after intramuscular injection | 
| Steady state concentration (Css) for IV treatment group |  | from 180 min to 240 min | 
| Hypoglycaemic episodes |  | from screening (visit 1) to follow-up visit (2-21 days after last trial product administration) | 
| Adverse Events (AEs) |  | from first trial related activity to follow-up visit (2-21 days after last trial product administration) |