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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676819
• Other study ID #: ANA-1416
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2008
• Last updated: March 15, 2017
• Start date: January 10, 2002
• Est. completion date: July 19, 2002

Study information

• Verified date: March 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 19, 2002
• Est. primary completion date: July 19, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin aspart

• human insulin

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Krones R, Schütte C, Heise T. The rapid-acting properties of insulin aspart are preserved in elderly people with type 2 diabetes. Diabetes Obes Metab. 2009 Jan;11(1):41-4. doi: 10.1111/j.1463-1326.2008.00988.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose infusion rate		in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
Secondary	AUCGIR(0-300 min) the area under the GIR profile		in the interval 0-300 minutes post dosing
Secondary	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)
Secondary	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)
Secondary	GIRmax: the maximal GIR value		tmax, GIR: the time to maximal GIR value
Secondary	early and late t50%, GIR		the time to early and late half-maximal GIR value
Secondary	AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile		in the interval 0-60 minutes post dosing
Secondary	AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile		in the interval 0-300 minutes post dosing
Secondary	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)
Secondary	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)
Secondary	Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration

External Links

•   Clinical Trials at Novo Nordisk