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

NCT ID: NCT00676819

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-10

Study Completion Date

2002-07-19

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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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insulin aspart

Intervention Type DRUG

human insulin

Intervention Type DRUG

Other Intervention Names

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ANA NovoRapid

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Cologne, , Germany

Site Status

Countries

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Germany

References

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Krones R, Schutte 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.

Reference Type RESULT
PMID: 19120432 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-1416

Identifier Type: -

Identifier Source: org_study_id

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