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

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin aspart

Drug: human insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00676819

ANA-1416

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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