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
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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COMPLETED
PHASE4
19 participants
INTERVENTIONAL
2002-01-10
2002-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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insulin aspart
human insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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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
Countries
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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ANA-1416
Identifier Type: -
Identifier Source: org_study_id
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