A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

Official Title
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This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Faster-acting insulin aspart
* Drug: Insulin Aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25. Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening HbA1C below or equal to 9.5 % based on central laboratory analysis Exclusion Criteria: Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faster Aspart<br> | Drug: Faster-acting insulin aspart<br>* A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.<br>|
| Active Comparator: Insulin Aspart<br> | Drug: Insulin Aspart<br>* A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | From 0 to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum insulin aspart concentration |  | Within 0 to 12 hours after dosing | 
| Area under the glucose infusion rate curve |  | From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing) | 
| Maximum glucose infusion rate |  | Within 0 to 12 hours after dosing |