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

• Status: Completed
• Trial end date: 2002-07-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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