Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.

Official Title
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Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin aspart
* Drug: human insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Duration of diabetes for at least 12 months Current treatment with human insulin or insulin analogues for at least 6 months BMI equal to or below 35 kg/m2 HbA1c equal to or greater than 10.0 % No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study Exclusion Criteria: History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject Current treatment with systemic corticosteroids Any positive reaction of drug of abuse or alcohol screen Cardiac problems defined as: decompensated heart failure and/or angina pectoris Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic Known or suspected allergy to trial product or related products Blood donation of more than 500 ml within the last 12 weeks The receipt of any investigational drug within 4 weeks prior to this trial

Ages Eligible for Study
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Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|
|Drug: human insulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose infusion rate |  | in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCGIR(0-300 min) the area under the GIR profile |  | in the interval 0-300 minutes post dosing | 
| AUCGIR(0 min-end of clamp) the area under the GIR profile |  | in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) | 
| AUCGIR(300min-end of clamp) the area under the GIR profile |  | in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) | 
| GIRmax: the maximal GIR value |  | tmax, GIR: the time to maximal GIR value | 
| early and late t50%, GIR |  | the time to early and late half-maximal GIR value | 
| AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile |  | in the interval 0-60 minutes post dosing | 
| AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile |  | in the interval 0-300 minutes post dosing | 
| AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile |  | in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) | 
| AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile |  | in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) | 
| Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration |  |  |